CCI approves acquisition of Bharat Serums and Vaccines by Mankind Pharma

New Delhi: Competition Commission of India has approved the acquisition of Bharat Serums and Vaccines Limited by Mankind Pharma Ltd.

The proposed transaction involves the acquisition of 100% shareholding of Bharat Serums and Vaccines Limited (BSV) by Mankind Pharma Ltd. (Mankind) (Proposed Combination).

Mankind is a public listed company and is engaged in developing, manufacturing, and marketing a diverse range of pharmaceutical finished dosage formulations (FDFs) across various acute and chronic therapeutic areas, as well as several consumer healthcare products such as condoms, emergency contraceptives, pregnancy tests, vitamins, minerals, nutrients, antacids and anti-acne preparations segments. Through its subsidiaries, Mankind is also engaged in, inter alia, the manufacture and sale of active pharmaceutical ingredients (APIs), pharmaceutical intermediaries, and packaging products for pharmaceutical products.

BSV, along with its subsidiaries, is engaged in research, development, licensing, manufacturing, importing, exporting, marketing and distribution of: (a) FDFs and APIs; (b) biotech and biological formulations and/or API; (c) food and health supplements; (d) medical devices; and (e) ayurvedic medicines; in each case, in the therapeutic areas such as gynaecology, in-vitro fertilisation, critical care and/or emergency medicines for human use. In India, the activities of BSV (including its wholly owned Indian subsidiary, BSV Pharma Private Limited, which is in the process of merging with BSV) are limited to developing, manufacturing, and marketing a range of biological, biotech, and pharmaceutical products in the therapeutic areas of women’s health, critical care, IUI-IVF, and emergency medicine.

Detailed order of the Commission will follow.

Read also: Mankind Pharma board to consider fund raising

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Sassoon Hospital doctor conned by cyber fraudsters, loses Rs 25 lakh

Pune: A senior woman doctor from Pune’s Sassoon Hospital has fallen victim to an elaborate online scam, losing Rs 25 lakh to fraudsters who posed as high-ranking officials from the Mumbai police and the Central Bureau of Investigation (CBI).

The 62-year-old doctor, a resident near Sadhu Vaswani Chowk in Pune, was targeted by cybercriminals who claimed she was under investigation for alleged involvement in a human trafficking and money laundering case, reports The Indian Express.  
Also Read:MBBS Admissions: SC upholds HC order quashing Widened Definition of NRI Quota
According to a complaint lodged at Pune City’s Cyber police station, the incident began on September 16, 2024, when the victim received a WhatsApp call from an individual posing as a representative of a telecom company. The caller informed her that her phone number would be deactivated within two hours. Concerned, the doctor inquired further and was soon connected to another person claiming to be Pradip Sawant, a police officer from Mumbai.
The fraudster sent the doctor a document over WhatsApp, claiming it was an arrest warrant issued by a court in Andheri. He alleged that she was involved in a financial fraud case and that her case had been handed over to the CBI for further investigation. Despite the victim’s denial of wrongdoing, the scam continued escalating.
The next day, she received another WhatsApp call from someone claiming to be a CBI officer. This individual requested details about her bank account balances under the pretence of conducting an investigation. Later, the fraudster demanded that she transfer Rs 25 lakh to a specified bank account to “assist in the investigation,” assuring her that the money would be returned once the inquiry was completed.
Also Read:Digital Arrest: How Doctors are becoming soft targets

Trusting the fraudsters, the victim transferred the amount via RTGS. However, when the fake CBI officer demanded additional funds, the doctor grew suspicious and immediately filed a complaint at the Cyber police station.
Authorities have registered a case under various sections of the Bharatiya Nyaya Sanhita (BNS) and the Information Technology (IT) Act. They are investigating the identity of the fraudsters, including the holder of the bank account to which the funds were transferred.
The incident serves as a reminder of the rising threat of cyber fraud, and police are urging the public to remain cautious when receiving unsolicited calls or messages from individuals claiming to represent law enforcement agencies.

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Breaking News: Doctor Shot Dead in Delhi Hospital

New Delhi: In a shocking development, a Delhi-based doctor was shot dead by two men inside Nima Hospital in the Jaitpur area, news agency ANI has reported.

This incident was reported from the Kalindi Kunj Police Station area. The staff at Nima Hospital have informed that these two men had come to the hospital with an injury.

After receiving treatment and dressing from the hospital, they allegedly demanded to meet the doctor. Once they entered the doctor’s cabin, they shot him dead, Delhi Police have informed ANI.

Also Read: Ayurveda doctor murder in Ghaziabad: Two sharpshooters arrested, prime suspect still at large

The deceased doctor has been identified as Javed Akhtar.

As per the latest media report by the Times of India, the goons shot him from close range. Currently, the Police are analyzing the CCTV footage to identify and arrest the suspects involved in the murder.

This sudden attack on the Delhi-based doctor comes at a time when doctors across the nation have been demanding to ensure their safety at workplace, following the recent rape and murder of a PG trainee doctor at Kolkata-based RG Kar Medical College and Hospital. Taking cognisance of the same, the Supreme Court has set up a National Task Force to draft an action plan to ensure the safety and security of doctors and healthcare workers.

Also Read: UP BAMS doctor shot dead by three miscreants

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USFDA grants priority review to AstraZeneca-Daiichi Sankyo Enhertu for HER2-low, HER2 Ultralow Breast Cancer

AstraZeneca and Daiichi Sankyo’s supplemental Biologics License Application (sBLA) for Enhertu (trastuzumab deruxtecan) has been accepted and granted Priority Review in the US for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer who have received at least one endocrine therapy in the metastatic setting based on the positive results from the DESTINY-Breast06 Phase III trial which compared Enhertu to chemotherapy.

The Food and Drug Administration (FDA) grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available options by demonstrating safety or efficacy improvements, preventing serious conditions or enhancing patient compliance. The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, is anticipated during the first quarter of 2025.

Enhertu was also recently granted Breakthrough Therapy Designation (BTD) by the FDA in this setting. BTD accelerates the development and regulatory review of potential new medicines intended to treat a serious condition and address a significant unmet medical need.

HR-positive, HER2-negative is the most common breast cancer subtype, accounting for approximately 70% of all breast cancers. Despite being classified as HER2-negative, many of these tumours still carry some level of HER2 expression. It is estimated that up to 85-90% of tumours historically classified as HR-positive, HER2-negative, may be HER2-low or HER2-ultralow.

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said, “While endocrine therapies are widely used in the initial treatment of HR-positive metastatic breast cancer, most patients see limited benefit with additional lines of treatment, and subsequent chemotherapy is associated with poor response rates and outcomes. The results from DESTINY-Breast06 show that Enhertu has the potential to evolve the current HR-positive treatment landscape and become the first targeted treatment for patients with HER2-low or HER2-ultralow expression following endocrine therapy.”

Ken Takeshita, Global Head, R&D, Daiichi Sankyo, said, “This Priority Review highlights the potential to expand the existing indication of Enhertu in HER2-low metastatic breast cancer to include use in an earlier disease setting as well as in a broader patient population that includes HER2-ultralow. We look forward to working closely with the FDA with the goal of bringing Enhertu to more patients as quickly as possible.”

The sBLA is based on data from the DESTINY-Breast06 Phase III trial presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and recently published in The New England Journal of Medicine.

In the trial, Enhertu reduced the risk of disease progression or death by 37% by blinded independent central review (BICR) versus chemotherapy (hazard ratio [HR] 0.63; 95% confidence interval [CI] 0.53-0.75; p<0.0001) in the overall trial population. Median PFS was 13.2 months with Enhertu compared to 8.1 months with chemotherapy.

Results were consistent between patients with HER2-low expression and HER2-ultralow expression. In the primary endpoint analysis of patients with HER2-low expression, Enhertu showed a median PFS of 13.2 months compared to 8.1 months for chemotherapy (HR 0.62; 95% CI 0.51-0.74; p<0.0001). In a prespecified exploratory analysis of patients with HER2-ultralow expression, Enhertu showed a median PFS of 13.2 months versus 8.3 months, respectively (HR 0.78; 95% CI 0.50-1.21).

The safety profile of Enhertu in DESTINY-Breast06 was consistent with previous clinical trials of Enhertu in breast cancer with no new safety concerns identified.

Enhertu is a specifically engineered HER2-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.

Enhertu is already approved in more than 65 countries, including the US, for patients with HER2-low metastatic breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial.

Read also: Lung cancer drug: AstraZeneca India wins CDSCO nod for Durvalumab for specified additional indication

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Time-restricted eating tied to greater blood sugar control and fat loss than standard nutrition counseling: Study

A randomized control trial of adults with metabolic syndrome evaluated the effect of time-restricted eating (TRE) on glucose control, fat mass, and weight loss. The data revealed that TRE led to greater modest improvement in glucose control and decreases in weight and fat mass when coupled with standard nutritional counseling than standard nutritional counseling alone. The study is published in Annals of Internal Medicine.

Researchers from the The Salk Institute and UCSD Medicine studied data from 108 adult participants with metabolic syndrome (MetS), elevated BMI, and elevated HbA1c or fasting glucose characteristic of prediabetes.

They aimed to assess the efficacy of personalized TRE in participants on top of standard nutritional counseling to determine the effects of TRE as a lifestyle intervention. Researchers randomly assigned participants into two groups that had different interventions; in the first group, participants were given standardized lifestyle and nutritional recommendations and advised to continue their eating patterns.

The second group was given the same nutritional recommendations, but they were also assigned to a personalized 8 to 10 hour eating window. Researchers remotely monitored the intervention for three months, during which the participants logged the timing of dietary intake in the myCircadianClock (mCC) app every day. The primary outcome was changes in fasting glucose, while secondary outcomes included changes in HbA1c and cardiometabolic parameters. Results found that, compared to the group receiving standard nutritional guidance, the TRE group not only had a greater decrease of weight, but a higher proportion of the weight lost was from fat-suggesting TRE likely poses a lower risk for deterioration of muscle associated with weight loss.

Further, while the changes were modest, the TRE group observed greater improvement in blood sugar control and hemoglobin A1c levels. Ultimately, the data indicates that TRE is an effective practical lifestyle intervention with benefits for glycemic regulation and cardiometabolic health. The study contributes to the library of existing research on TRE and metabolic syndromes. In addition, its methodological innovation in using the mCC app enables future studies to be remote and at a larger scale.

Reference:

Emily N.C. Manoogian, Michael J. Wilkinson, Monica O’Neal, Kyla Laing, Justina Nguyen, BS, David Van,  Ashley Rosander, Time-Restricted Eating in Adults With Metabolic Syndrome: A Randomized Controlled Trial, Annals of Internal Medicine, https://doi.org/10.7326/M24-0859.

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Sacubitril/Valsartan Shows No Superiority Over Enalapril in Pediatric HF, Study Finds

Researchers have established that sacubitril/valsartan, an angiotensin receptor-neprilysin inhibitor (ARNI), is not superior to enalapril in the treatment of heart failure (HF) in children who have systemic left ventricular systolic dysfunction (LVSD). A recent trial known as the PANORAMA-HF trial, was published in the journal Circulation conducted by Shaddy R. and colleagues.

The objective of the PANORAMA-HF trial was to determine whether sacubitril/valsartan was better than enalapril in treating pediatric patients who suffered from HF due to LVSD. In this randomized trial, 375 children aged between 1 month and 18 years were assigned to sacubitril/valsartan or enalapril groups.

The main outcome measure was a global rank score, ranking the patients from worst to best on clinical endpoints that included death, urgent heart transplant listing, need for mechanical life support, worsening HF, NYHA/Ross class, Patient Global Impression of Severity (PGIS), and the Pediatric Quality of Life Inventory (PedsQL) physical functioning domain. Exploratory analyses included changes in NT-proBNP levels, a biomarker for heart failure.

  • 375 children (mean age: 8.1±5.6 years, 52% female) were randomized to receive either sacubitril/valsartan (n=187) or enalapril (n=188) in the trial.

  • No statistically significant difference was established between the groups in the 52-week endpoint defined as the global rank, with a probability value of 0.52 (95% CI: 0.47-0.58) and odds at the Mann-Whitney test of 0.91 (95% CI: 0.72-1.14), evidencing no statistical superiority of sacubitril/valsartan over enalapril.

  • Both treatment groups showed marked reductions in NYHA/Ross classification, PGIS, Patient Global Impression of Change, and NT-proBNP levels at 52 weeks with no between-group differences.

  • Safety of both agents seems to be equivalent with adverse event rates reached by 88.8% in the sacubitril/valsartan and 87.8% in the enalapril; hence, sacubitril/valsartan seems very well tolerated in children.

The researchers concluded that both drugs are associated with clinically significant improvements over a period of 52 weeks, with similarities between their safety profiles; thus, safer alternatives for pediatric patients exist. Further research is needed to confirm potential benefits in specific pediatric populations with HF or with other drugs in addition to sacubitril/valsartan.

Reference:

Shaddy, R., Burch, M., Kantor, P. F., Solar-Yohay, S., Garito, T., Zhang, S., Kocun, M., Mao, C., Cilliers, A., Wang, X., Canter, C., Rossano, J., Wallis, G., Menteer, J., Daou, L., Kusa, J., Tokel, K., Dilber, D., Xu, Z., … Bonnet, D. (2024). Sacubitril/valsartan in pediatric heart failure (PANORAMA-HF): A randomized, multicenter, double-blind trial. Circulation. https://doi.org/10.1161/circulationaha.123.066605

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Study Links Elevated Beta-Hydroxybutyrate Levels to Increased DKA Risk in Type 1 Diabetes Patients on Sotagliflozin

USA: A recent study published in Diabetes Technology & Therapeutics has revealed a concerning connection between elevated beta-hydroxybutyrate (BHB) levels and the risk of diabetic ketoacidosis (DKA) in adults with type 1 diabetes (T1D) receiving sotagliflozin, an SGLT1/2 inhibitor. The findings highlight the need for careful monitoring and patient education regarding DKA risks in this population.

According to the authors, incremental increases in baseline BHB levels and BHB changes from baseline (ΔBHB) were associated with a greater risk of DKA, regardless of the treatment. Additionally, the authors found that adding sotagliflozin to insulin therapy led to higher median BHB levels over 24 weeks in patients with type 1 diabetes, which was linked to an increase in DKA events.

DKA is a serious and potentially life-threatening condition characterized by high blood sugar, ketone accumulation, and metabolic acidosis. It is particularly concerning in individuals with T1D, who are already at a greater risk for this complication. Sodium-glucose cotransporter inhibitors may elevate BHB levels in patients who require insulin. Considering this, Schafer Boeder, Division of Endocrinology and Metabolism, Department of Medicine, University of California, San Diego, La Jolla, California, USA, and colleagues identified factors associated with changes in beta-hydroxybutyrate from baseline and the occurrence of diabetic ketoacidosis in patients with type 1 diabetes receiving sotagliflozin as an adjunct to insulin therapy.

For this purpose, the researchers conducted a post hoc analysis comparing ΔBHB levels in adults with T1D who received either 400 mg of sotagliflozin or a placebo for six months. They assessed clinical and metabolic factors related to ΔBHB and utilized logistic regression models to identify predictors associated with BHB levels greater than 0.6 and 1.5 mmol/L (inTandem3 population; N = 1,402) or with DKA events in a pooled analysis (inTandem1–3; N = 2,453).

The study led to the following findings:

  • From baseline (median, 0.13 mmol/L), median fasting BHB increased by 0.04 mmol/L at 24 weeks with sotagliflozin versus placebo; 67% of patients had no or minimal changes in BHB over time.
  • Factors associated with on-treatment BHB >0.6 or >1.5 mmol/L included baseline BHB and sotagliflozin use.
  • Age, insulin pump use, sotagliflozin use, baseline BHB, and ΔBHB were significantly associated with DKA episodes.
  • Independent of treatment, DKA risk increased by 18% with each 0.1-mmol/L increase in baseline BHB and 8% with each 0.1-mmol/L increase from baseline.

The results highlight the significance of patient selection based on BHB testing before initiating SGLT inhibitors and the necessity for education on the risks, mitigation strategies, identification, and treatment of ketosis and DKA.

“Additionally, our findings indicate that BHB monitoring should be implemented for all patients with type 1 diabetes, regardless of whether they are using SGLT inhibitors. However, further research is needed to establish the optimal frequency for BHB monitoring,” the researchers concluded.

Reference:

Boeder S, Davies MJ, McGill JB, Pratley R, Girard M, Banks P, Pettus J, Garg S. Beta-Hydroxybutyrate Levels and Risk of Diabetic Ketoacidosis in Adults with Type 1 Diabetes Treated with Sotagliflozin. Diabetes Technol Ther. 2024 Sep;26(9):618-625. doi: 10.1089/dia.2023.0605. Epub 2024 May 13. PMID: 38441906.

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Early Dapagliflozin Administration Cuts Heart Failure Admissions, Study Finds

Japan: A recent study has shed light on the effects of early versus late administration of dapagliflozin in patients suffering from decompensated heart failure (HF). Dapagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, has gained attention for its potential benefits in managing heart failure, but the timing of its initiation remains a key consideration in clinical practice.

The study, published in The British Journal of Cardiology, revealed that early administration of dapagliflozin notably decreased hospital admissions for heart failure within one year of treatment. However, there were no significant differences in 24-hour urine volume, cardiac death rates, ejection fraction (EF), glomerular filtration rate (GFR), hemoglobin levels, NT-proBNP levels, or side effects.

SGLT2 inhibitors have shown beneficial effects in heart failure (HF) patients. However, the impact of dapagliflozin, specifically in individuals with decompensated HF, is still not well understood. To fill this knowledge gap, Takahiro Tokuda, Interventionist, Nagoya Heart Center, Higashi-ku, Nagoya, Aichi, Japan, and colleagues aimed to compare the safety and efficacy of early and late dapagliflozin administration for decompensated HF.

For this purpose, the researchers analyzed data from 70 patients diagnosed with heart failure at a Japanese heart center between December 2020 and November 2021. They conducted a retrospective study using propensity score matching to compare the clinical outcomes of early versus late dapagliflozin administration for decompensated heart failure.

The primary endpoint focused on hospital admissions for heart failure within one year of starting dapagliflozin. Secondary endpoints included evaluations of 24-hour urine volume, cardiac death, changes in ejection fraction (EF), blood pressure, glomerular filtration rate (GFR), hemoglobin levels, N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels, and side effects over the same period. Ultimately, the analysis included 15 matched pairs of patients.

The researchers reported the following findings:

  • Of the 70 patients analyzed, 15 received early dapagliflozin administration, while 55 were given it later.
  • After propensity score matching (PSM), 15 matched pairs were included, showing no significant differences in baseline characteristics between the groups.
  • The average age of patients was 73 years, with 53% male, 27% having ischemic heart failure, a mean left ventricular ejection fraction of 45%, and a median NT-proBNP level of 4,481 pg/ml.
  • The average duration of dapagliflozin treatment was significantly longer in the late group (33.5 ± 17.8 days) compared to the early group (1.7 ± 0.8 days).
  • The heart failure admission rate was significantly lower in the early dapagliflozin group (0%) compared to the late group (20%).
  • There were no significant differences in 24-hour urine volume, cardiac death, changes in ejection fraction, glomerular filtration rate, hemoglobin levels, or NT-proBNP levels within one year.
  • The incidence of side effects was similar between both groups, with only one case of dehydration noted in the late-administration group.

The researchers noted several limitations, including a small patient cohort and its retrospective design, which may introduce selection bias. It focused solely on Japanese patients with decompensated heart failure, limiting generalizability. Additionally, findings are specific to dapagliflozin, necessitating further prospective studies to explore other SGLT2 inhibitors.

“Overall, this study found that early administration of dapagliflozin significantly decreased heart failure admissions within one year of treatment. However, there were no observed differences in ejection fraction, glomerular filtration rate, hemoglobin levels, NT-proBNP levels, or side effects,” the researchers concluded.

Reference:

DOI: 10.5837/bjc.2024.010

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Triple Therapy: GEMI + DAPA Enhances Glycemic Control for Type 2 Diabetics on Metformin, SOLUTION 2 study

South Korea: Gemigliptin and dapagliflozin dual add-on therapy (GEMI + DAPA) along with metformin is safe, effective, and well-tolerated, particularly for type 2 diabetes (T2D) patients with poor glycemic control on metformin alone, the SOLUTION 2 study has shown.

The findings, published in Diabetes, Obesity and Metabolism, suggest that the triple combination therapy provides robust glycemic control without notable safety concerns.

Kyong Soo Park, Department of Internal Medicine, Seoul National University Hospital, Seoul, South Korea, and colleagues conducted the study to evaluate the safety and efficacy of gemigliptin and dapagliflozin dual add-on therapy to metformin in T2D patients who had inadequate glycaemic control on metformin alone, compared with a single add-on of either gemigliptin (GEMI) or dapagliflozin (DAPA) to metformin.

The randomized, double-blind, double-dummy, active-controlled, parallel-group, phase 3 study (SOLUTION 2) included 469 type 2 diabetes patients treated with a stable metformin dose for eight weeks or longer. They were randomized to receive GEMI + DAPA (n = 157) and either GEMI (n = 156) or DAPA (n = 156). The main focus of the study was to measure the difference in HbA1c levels from baseline after 24 weeks of treatment.

The following were the key findings of the study:

  • Baseline characteristics, including body mass index and T2D duration, were similar among groups.
  • At week 24, the least square mean changes in HbA1c from baseline were −1.34% with GEMI + DAPA, −0.90% with GEMI (difference between GEMI + DAPA versus GEMI −0.44%) and −0.78% with DAPA (difference between GEMI + DAPA versus DAPA −0.56%).
  • Both upper CIs were less than 0, demonstrating the superiority of GEMI + DAPA for lowering HbA1c.
  • The rates of responders achieving HbA1c less than 7% and less than 6.5% were greater with GEMI + DAPA (84.9%, 56.6%) than with GEMI (55.3%, 32.2%) and DAPA (49.3%, 15.3%).
  • The incidence rate of adverse events was similar across groups, with low incidence rates of hypoglycemia, urinary tract infection, and genital infection.

As diabetes continues to pose a global health challenge, innovative treatment strategies like the dual add-on therapy of gemigliptin and dapagliflozin presented in the SOLUTION 2 study offer renewed optimism for improved patient outcomes. With further research and clinical validation, this approach could potentially redefine standards of care in managing type 2 diabetes, ushering in a new era of personalized and effective treatment options.

“The SOLUTION 2 study provides compelling evidence supporting the efficacy, safety, and holistic benefits of combining gemigliptin and dapagliflozin for patients with inadequately controlled type 2 diabetes, marking a significant advancement in diabetes therapeutics,” the researchers concluded.

Reference:

Han KA, Hwang YC, Moon SJ, Cho HC, Yoo HJ, Choi SH, Chon S, Kim KA, Kim TN, Kang JG, Park CY, Won JC, Cho E, Kim J, Park KS. Dual add-on therapy of gemigliptin and dapagliflozin in patients with type 2 diabetes inadequately controlled with metformin alone: The SOLUTION 2 study. Diabetes Obes Metab. 2024 Jul 8. doi: 10.1111/dom.15717. Epub ahead of print. PMID: 38978173.

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FDA approves first biologic treatment for COPD

The US Food and Drug Administration has approved dupilumab (Dupixent) as the first biologic treatment for adults with chronic obstructive pulmonary disease (COPD).

Dupixent is the first biologic medicine approved in the US to treat these patients.

Jean Wright, M.D. Chief Executive Officer at The COPD Foundation “People living with inadequately controlled COPD have long awaited new medicines to help manage the daily suffering they experience from breathlessness, coughing, wheezing, exhaustion and unpredictable hospitalization. These patients often struggle with everyday activities many people take for granted such as taking a walk or running errands outside the home. We welcome the approval of this new therapeutic option to offer patients a new way to help gain better control of their disease.”

Paul Hudson Chief Executive Officer at Sanofi “Dupixent has already shown it can revolutionize the treatment paradigm of many diseases driven in part by type 2 inflammation with high unmet medical needs, with one million patients being treated globally across all currently approved indications. With today’s approval, Dupixent once again paves the way and becomes the first and only approved add-on biologic medicine for inadequately controlled COPD, giving patients living with this devastating disease the chance to look forward to the potential of improved breathing and a life with fewer exacerbations.”

The FDA approval is based on data from two landmark pivotal phase 3 studies (BOREAS and NOTUS) that evaluated the efficacy and safety of Dupixent compared to placebo in adults currently on maximal standard-of-care inhaled therapy (nearly all on triple therapy) with inadequately controlled COPD and blood eosinophils ≥300 cells per μL. Patients who received Dupixent in BOREAS (n=468) and NOTUS (n=470) experienced the following outcomes, respectively, compared to placebo (BOREAS n=471; NOTUS n=465):

  • 30% and 34% reduction in the annualized rate of moderate or severe COPD exacerbations over 52 weeks, the primary endpoint.
  • 74mL and 68mL numerically greater improvements in post-bronchodilator FEV1 from baseline at week 12 compared to placebo, sustained at 52 weeks. Statistically significant improvements of similar magnitude were observed in pre-bronchodilator FEV1 from baseline at 12 and 52 weeks, a key secondary endpoint.
  • 51% response in a health-related quality of life measure in both trials compared to 43% and 47% with placebo at 52 weeks, as assessed by a 4-point improvement on the St. George’s Respiratory Questionnaire (SGRQ).

Safety results in both studies were generally consistent with the known safety profile of Dupixent in its approved indications. In pooled BOREAS and NOTUS data, the most common adverse events (>2%) more frequently observed in patients on Dupixent compared to placebo were viral infection, headache, nasopharyngitis, back pain, diarrhea, arthralgia, urinary tract infection, local administration reaction, rhinitis, eosinophilia, toothache, and gastritis. While less common, cholecystitis was reported in 0.6% of patients on Dupixent compared to 0.1% of patients on placebo.

George D. Yancopoulos, M.D., Ph.D .Board Co-Chair, President and Chief Scientific Officer at Regeneron “This latest FDA approval for Dupixent represents new hope for the hundreds of thousands of COPD patients in the US who can sometimes struggle just to breathe during their everyday lives. Dupixent has a proven track record as a first-in-class medicine, providing benefit to the many patients suffering from type 2 inflammatory related diseases such as asthma and atopic dermatitis. This latest approval represents an important next chapter for Dupixent, giving those with COPD a novel option that has demonstrated the unprecedented ability to help patients experience fewer exacerbations, while also helping them breathe better and improve quality of life in phase 3 studies.”

The FDA evaluated Dupixent under Priority Review, which is reserved for medicines that represent potentially significant improvements in efficacy or safety in treating serious conditions. In July 2024, Sanofi and Regeneron announced that the European Medicines Agency approved Dupixent as an add-on maintenance treatment for adults with uncontrolled COPD characterized by raised blood eosinophils. Submissions are currently under review with other regulatory authorities around the world, including in Japan.

About COPD

COPD is a respiratory disease that damages the lungs and causes progressive lung function decline and is the fourth leading cause of death worldwide. Symptoms include persistent cough, excessive mucus production and shortness of breath that may impair the ability to perform routine daily activities, which may lead to sleep disturbances, anxiety, and depression. COPD is also associated with a significant health and economic burden due to recurrent acute exacerbations that require systemic corticosteroid medicine and/or antibiotics. Smoking and exposure to noxious particles are key risk factors for COPD, but even individuals who quit smoking can still have progressive lung disease.

About half of COPD patients continue to experience exacerbations despite being on triple inhaled therapy. In the US, approximately 300,000 people live with inadequately controlled COPD and an eosinophilic phenotype. Patients with an eosinophilic phenotype contribute to an ~30% increase in exacerbations and an increased risk of COPD-related re-hospitalizations within a year.

About the Dupixent COPD phase 3 study program

BOREAS and NOTUS were replicate, randomized, phase 3, double-blind, placebo-controlled studies that evaluated the efficacy and safety of Dupixent in adults who were current or former smokers with moderate-to-severe COPD with an eosinophilic phenotype, as defined by blood eosinophils ≥300 cells per µL. The studies included adults with COPD across a broad range of clinical presentations, including those with chronic bronchitis and emphysema. The studies enrolled 1,874 patients who were aged 40 to 80 years in BOREAS and 40 to 85 years in NOTUS.

During the 52-week treatment period, patients in BOREAS and NOTUS received Dupixent or placebo every two weeks added to a maximal standard-of-care inhaled triple therapy of ICS, LABA and LAMA. Double maintenance therapy, which included LABA and LAMA, was allowed if ICS was not appropriate.

The primary endpoint for BOREAS and NOTUS evaluated the annualized rate of acute moderate or severe COPD exacerbations. Key secondary endpoints included change from baseline in lung function (assessed by pre-bronchodilator forced expiratory volume [FEV1]) at 12 and 52 weeks, change from baseline at 52 weeks in SGRQ total score compared to placebo, and safety.

The results of both BOREAS and NOTUS were separately published in The New England Journal of Medicine.

About Sanofi and Regeneron’s COPD Clinical Research Program

Sanofi and Regeneron are motivated to transform the treatment paradigm of COPD by examining the role different types of inflammation play in the disease progression through Dupixent, a first-in-class biologic, and the investigation of itepekimab.

Dupixent inhibits the signaling of the interleukin-4 (IL4) and interleukin-13 (IL13) pathways and the program focuses on a specific population of people with evidence of type 2 inflammation. Itepekimab is a fully human monoclonal antibody that binds to and inhibits interleukin-33 (IL33), an initiator and amplifier of broad inflammation in COPD.

Itepekimab is currently under clinical investigation for COPD in two phase 3 studies and its safety and efficacy have not been evaluated by any regulatory authority.

About Dupixent

Dupixent is a fully human monoclonal antibody that inhibits the signaling of the IL4 and IL13 pathways and is not an immunosuppressant. The Dupixent development program has shown significant clinical benefit and a decrease in type 2 inflammation in phase 3 studies, establishing that IL4 and IL13 are two of the key and central drivers of type 2 inflammation that play a major role in multiple related and often co-morbid diseases.

Sanofi and Regeneron are committed to helping patients in the US who are prescribed Dupixent gain access to the medicine and receive the support they may need with the DUPIXENT MyWay® program. 

Dupixent has received regulatory approvals in more than 60 countries in one or more indications including certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis, chronic spontaneous urticaria, and COPD in different age populations. More than 1,000,000 patients are being treated with Dupixent globally.

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