Aurobindo Pharma bags USFDA okay for Duchenne muscular dystrophy drug Deflazacort

Hyderabad: Aurobindo Pharma Limited has announced that the Company has received final approval from the US Food & Drug
Administration (USFDA) to manufacture and market Deflazacort Tablets, 6 mg, 18 mg, 30 mg, and 36 mg, which
is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), EMFLAZA tablets 6 mg, 18
mg, 30 mg and 36 mg of PTC Therapeutics Inc.

The product will be launched in February 2024.
The approved product has an estimated market size of US$ 67 million for the three months ending September
2023, according to PTC Therapeutics Inc.

Aurobindo now has a total of 502 ANDA approvals (482 Final approvals
and 20 tentative approvals) from USFDA.

Deflazacort Tablets, 6 mg, 18 mg, 30 mg, and 36 mg is indicated for the treatment of Duchenne muscular
dystrophy (DMD) in patients 5 years of age and older.

Duchenne muscular dystrophy (DMD) is a severe type of muscular dystrophy mainly impacting males. Onset of muscle weakness typically begins around age four and progresses rapidly. Initial muscle deterioration often affects the thighs and pelvis before spreading to the arms, leading to difficulties in standing up. By around age 12, most individuals affected by DMD lose the ability to walk. Affected muscles may appear enlarged due to increased fat content, and scoliosis is a common complication. Some individuals may also experience intellectual disabilities.

Aurobindo Pharma Limited is an integrated global pharmaceutical company headquartered in Hyderabad, India. The
Company develops, manufactures, and commercializes a wide range of generic pharmaceuticals, branded
specialty pharmaceuticals and active pharmaceutical ingredients globally in over 150 countries.
The company has 25 manufacturing and packaging facilities that are approved by leading regulatory agencies
including USFDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC, Brazil ANVISA.

The
company’s product portfolio is spread over 7 major therapeutic/product areas encompassing CNS, AntiRetroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics and Anti-Allergic, supported by a strong R&D
set-up.

Read also: Aurobindo Pharma arm bags CDSCO panel recommendation for grant of marketing authorization of biosimilar trastuzumab

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Diabetes and Tiredness: Fact or Fiction? – Dr Kirti Samudra

Maintaining HbA1c levels below 7% is crucial for individuals with diabetes to ensure optimal blood sugar control and minimize the risk of complications.HbA1c, or glycated hemoglobin, reflects average blood sugar levels over several months. Keeping it within the recommended range helps reduce the risk of diabetes-related complications, including cardiovascular issues, nerve damage, and kidney problems. By actively managing HbA1c, individuals can mitigate these risks and lead a healthier life. Regular monitoring, lifestyle modifications, and medication adherence contribute to achieving the target HbA1c, promoting overall well-being for people with diabetes.

Contrary to the misconception that diabetes inevitably leads to constant fatigue, proper management, including medication adherence, balanced nutrition, and regular exercise, can significantly enhance energy levels and overall quality of life. Fatigue in diabetes may be linked to uncontrolled blood sugar, emphasizing the importance of HbA1c monitoring. By keeping HbA1c below 7%, individuals can proactively manage their condition, reduce fatigue, and foster a healthier, more energetic lifestyle, debunking the notion that diabetes inevitably results in persistent tiredness.

In this video, Dr Kirti Samudra, a Diabetologist from Maharashtra, discusses the importance of maintaining HbA1C levels within the recommended range while clarifying whether diabetes causes constant fatigue.

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Amrita Hospital Faridabad, IIT Hyderabad join hands to develop robot-assisted ultrasound system for cancer patients

Kochi: Dr Bhaskar Viswanathan, HoD, Department of Radiation Oncology, Amrita Hospital, Faridabad, has been recently selected for a research grant, meant to develop an indigenous robotic ultrasound for tumor motion and radiation hyperthermia for cancer treatment.

The technology would be developed in association with Dr. Avinash Eranki, Assistant Professor, Department of Biomedical Engineering at the Medical Ultrasound Research Laboratory of Indian Institute of Technology – Hyderabad, Eranki Labs Private Limited, and Amrita Centre for Advanced Robotics.

Also Read: Amrita Hospital doctors perform hand transplantation on 64-year-old man with kidney transplant

Dr. Bhaskar Viswanathan, Head of the Radiation Oncology Department at Amrita Hospital, Faridabad said, “It is a matter of immense pleasure and pride for us that we have been selected for this grant to indigenously develop a robot-assisted ultrasound system for image-guided therapies and hyperthermia for cancer patients. It is a non-invasive technique that uses focused ultrasound waves and has a huge potential in cancer treatment like tumor ablation, mild hyperthermia for radiotherapy and chemotherapy, and motion management during radiation delivery.”

“This cutting-edge technology will allow precise localization of lesions, enabling targeted and effective delivery of therapeutic radiation and avoiding damage to the surrounding tissue and organs. Robotic ultrasound plays an important role in guiding the delivery of hyperthermia by accurately locating the tumor and monitoring its motion during treatment. Real-time tracking can be crucial in ensuring that hyperthermia is delivered precisely to the intended target,” the doctor said.

He explained that tumors in the body can move due to factors like breathing and organ motion. Tracking this motion is crucial for accurately delivering radiation therapy. Robotic ultrasound systems can be used to track the movement of tumors in real-time. They use robotic arms equipped with ultrasound transducers to continuously monitor the tumor position during treatment, thus improving targeting accuracy.

Hyperthermia involves raising the temperature of the tumor region to make cancer cells more sensitive to radiation. It also improves blood flow to the tumor, enhancing the delivery of oxygen and chemotherapy. Combining hyperthermia with radiation therapy can significantly enhance the therapeutic effects and theoretically allow for theoretic lower radiation doses, minimizing damage to surrounding healthy tissue.

Dr. Avinash Eranki, Assistant Professor, Department of Biomedical Engineering, and CEO of Eranki Labs Pvt. Ltd. said, “The need for spatially precise and efficacious delivery of radiation and ultrasound energy is possibly key to improved outcomes in patients with debilitating cancer disease.”

“The collaboration with IIT Hyderabad and Eranki Labs Private Limited enhances the project’s scope, leveraging the expertise of both medical and engineering domains. This interdisciplinary partnership is crucial for advancing technology in cancer care, emphasizing a holistic approach to treatment innovation. We expect to complete the project in 3 years, the grant for which was provided to us by the Indian Council of Medical Research (ICMR),” added Dr. Viswanathan

Also Read: Amrita Hospital Kochi launches Interstitial Lung Disease and Sarcoidosis Clinics

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Understanding the Role of Gut Microbes in Parkinson’s Disease: Dr Poonam Chandrashekhar Awatare

The past 25 years have witnessed a concerning rise
in Parkinson’s Disease (PD) prevalence worldwide. Recent data suggest an 81%
increase in the incidence of PD – a neurodegenerative disorder between 2000 and
2019.

The 2019 estimate also says approximately 5.8 million individuals are
living with PD with significant disability caused by the disease impacting
their adjusted years of living.

Additionally, an alarming 3.2 million deaths
have been associated with PD in 2019 alone, which is a striking 100% rise since
the turn of the millennium. This information underscores the need for increased
awareness and effective interventions to address the growing impact of Parkinson’s
Disease.

The
increased prevalence of PD is due to:

  • Increasing awareness about symptoms – Over the years, there has
    been an increase in general awareness about the symptoms that has led to
    more and more people reporting to clinicians and getting diagnosed with
    PD.
  • Improved access to care – There have been tremendous advancements
    in medical and healthcare, providing people with better access to care,
    contributing to more and more people living with PD for extended years.
  • Longevity – The average onset of PD is around 60 years and above.
    With improved access to healthcare, there has been a generalized increase
    in the lifespan globally. Hence, the percentage of the population in the
    age group prone to PD has also increased.
  • Environmental factors such as exposure to the use of toxins and
    chemicals in pesticides and herbicides
  • Genetic factors
  • Increased incidence of head injuries

Recent research has also put forth various
hypotheses establishing the role of commensal gut bacteria in the development
of PD. These studies state that commensal gut bacteria have a connection with
the brain and contribute to neurodevelopment, brain function, and health.This
bi-directional communication between the gut and brain is often referred to as
the microbiome-gut-brain axis.

Microbes in the gut lumen can promote
inflammatory pathways, cause damage to enterocytes, and compromise gut
epithelial barrier integrity, leading to a leaky gut and release of bacterial
metabolites like lipopolysaccharides.

The bacterial metabolites can translocate
from the gut lumen to the bloodstream, compromise the gut lumen, and cause
systemic and neuro-inflammation in the brain.They can also cross the
blood-brain barrier, enter the brain, and release various cytokines and
chemokines that promote inflammation, forming the pathological foundation for
PD.

Immunoreactive alpha-synuclein aggregates that are
pathognomic for PD, are also found in peripheral endo-neuronal system in the
intestine, supporting the theory of gut role in PD.

Misfolded alpha-synuclein
may be induced by microbes at the intersection of the gut lumen and endoneurial
system and may propagate to neurons in the brain through the vagus nerve. All
these hypotheses suggest there might be a gut relationship for the pathogenesis
of Parkinson’s disease.

Management
of Parkinson’s Disease

Since PD is a neurodegenerative disease, it has no
definitive treatment or cure. However, the progression of symptoms can be
controlled with medical interventions. Intervening with prokinetics is one such
medical management that helps reverse the gut microbe dysbiosis (reduction in
the gut-friendly microbes) to improve gut health and promote the prevention of
bacterial translocation, reduction of system and neuronal inflammation, and
thereby, contribute to the prevention of PD.

Likewise, some precautions can help prevent PD or
slow the progression of symptoms including:

  • Avoiding the use of or exposure to pesticides and herbicides
  • Using organic food and increasing consumption of fresh and raw
    green vegetables in the regular diet
  • Adopting a healthy diet, avoiding canned fried foods, and regular
    or diet soda
  • Increased intake of omega-3 and vitamin D supplements
  • Maintenance of a good gut system with intake of probiotics
  • Regular aerobic exercises
  • Physical and emotional
    stress management

Disclaimer: The views expressed in this article are of the author and not of Medical Dialogues. The Editorial/Content team of Medical Dialogues has not contributed to the writing/editing/packaging of this article.

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Yoga and Mindfulness effective in reducing schizophrenia symptoms

Schizophrenia is a severe mental health issue. It impairs a person’s thinking, emotions, and behaviour. Those who suffer from this condition may seem detached from reality, causing distress for themselves and their loved ones.

According to a recent study published in Schizophrenia Research, yoga and mindfulness interventions are more effective compared to other mind-body therapies in mitigating the symptoms of schizophrenia.
This meta-analysis aims to evaluate and compare the effectiveness of different mind-body therapies for reducing schizophrenia symptoms. A systematic search was conducted using PubMed, Embase, Cochrane Library, Web of Science, and Scopus. Randomized controlled trials assessing the effects of mind-body therapies on schizophrenia patients were included. The search covered the period from inception to November 17th, 2022. The Cochrane risk of bias tool assessed the methodological quality of the trials. A network meta-analysis was conducted to compare the effects of Yoga, Mindfulness, Tai Chi, Baduanjin, and Yijinjing.
The following are the findings of the study:
  • 22 RCTs had a total of 2064 subjects.
  • Yoga and Mindfulness interventions were more effective than other mind-body therapies in reducing schizophrenia symptoms.
  • Specifically, Yoga improved PANSS-positive and PANSS-negative symptom scores with SUCRA 74.8 % and 80.4 % respectively.
  • Mindfulness improved PANSS-positive symptom scores with SUCRA 85.6%.
This research suggests that Yoga may be a potential therapy for schizophrenia, but the limited sample size and low quality of the studies included restrict the applicability of our results. They added that more high-quality research is needed to confirm our findings.
Reference:
Su Y, Pan X, Li H, Zhang G. Effects of mind-body therapies on schizophrenia: A systematic review and network meta-analysis. Schizophr Res. 2024 Jan 5;264:236-247. doi: 10.1016/j.schres.2023.12.030. Epub ahead of print. PMID: 38185028.

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Gestational diabetes mellitus not tied to increased all-cause mortality

A recent prospective cohort study investigated the potential link between the gestational diabetes mellitus (GDM) and long-term mortality. The major highlights of this study were published in the BMC Cardiovascular Diabetology.

This study was conducted from October 2022 to April 2023 and involved a total of 10,327 women with a pregnancy history to discern whether GDM, without subsequent overt diabetes, had any significant association with all-cause and cardiac mortality. The findings revealed critical insights into the health outcomes of women with a history of GDM. 5.3% of the participants had GDM alone, while 14.1% had overt diabetes. 758 deaths were recorded over a median follow-up period of 6.7 years.

This crucial findings of this study uncovered that GDM alone did not increase the risk of either all-cause or cardiac mortality. The participants in the GDM group showed comparable mortality rates to those without diabetes. Also, the group with overt diabetes faced a significantly higher risk of both all-cause and cardiac mortality when compared to their counterparts without diabetes.

The sensitivity analysis focused on women aged 50 or above and reinforced these findings. Among this subgroup, a history of GDM did not show any association with increased mortality risks. Overt diabetes remained significantly linked to heightened all-cause and cardiac mortality rates.

These findings challenge previous assumptions regarding the long-term health implications of gestational diabetes. While overt diabetes poses substantial risks, this research suggests that GDM alone may not contribute to the heightened mortality rates. These insights underscore the importance of distinguishing between different forms of diabetes and their respective impacts on long-term health outcomes.

Source: 

Ying, Q., Xu, Y., Zhang, Z., Cai, L., Zhao, Y., & Jin, L. (2024). Gestational diabetes mellitus and risk of long-term all-cause and cardiac mortality: a prospective cohort study. In Cardiovascular Diabetology (Vol. 23, Issue 1). Springer Science and Business Media LLC. https://doi.org/10.1186/s12933-024-02131-3

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Delhi AIIMS introduces Mohs micrographic surgery for skin cancer treatment

New Delhi: Our skin serves as the body’s protective barrier, yet without proper care, it can become susceptible to serious conditions like cancer.

The global incidence of cancer, including skin cancer, is on the rise. Every month, the All India Institute of Medical Sciences (AIIMS), Delhi treats 5 to 6 patients with skin cancer. 

To address this growing concern, AIIMS Delhi has introduced a new surgery for skin cancer treatment. Inaugurated by Professor M Srinivas, Director of AIIMS Hospital on Saturday, this new facility ensures that patients no longer need to seek treatment abroad. 

Also Read:International Epilepsy Day: Delhi AIIMS organizes public awareness programme

Dr Kaushal Verma, Head of Dermatology at AIIMS, explains that the surgery, known as Mohs micrographic surgery, offers precise tumour removal with minimal damage to healthy tissue. This technique, previously unavailable in India, promises improved healing and lower recurrence rates.

Dr Kaushal Verma, Head of the Department of Dermatology at AIIMS, explained that the surgery, known as Mohs micrographic surgery, offers precise tumour removal with minimal damage to healthy tissue.

AIIMS Delhi is the first hospital in the country to offer this surgery for skin cancer. Previously, patients had to travel abroad for this specialized treatment.

With the assistance of a team of six surgeons and three technicians from the USA, AIIMS Delhi has established itself as a centre for cutting-edge cancer care, aligning with its commitment to providing world-class treatment.

Dr Verma highlighted the benefits of Mohs micrographic surgery, emphasizing its ability to precisely remove cancerous tissue while preserving normal skin. “This results in smaller defects and improved cosmetic outcomes compared to conventional procedures,” he said.

Furthermore, Dr Verma stressed the importance of early detection and urged people to consult a doctor if they notice any rapidly growing, painful, or bleeding skin spots.

AIIMS Delhi, with its large number of patients, provides comprehensive care for cancer patients across various specialities. On average, the hospital sees about five to six skin cancer patients every month, who are treated by specialists from different departments, including dermatology, surgery, and oncology, he pointed out.

Also Read:AIIMS, ICMR begin multi-centre trial on HPV tests for detecting cervical cancer

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Administration of antioxidant vitamins may be useful in preventing and treating prostate cancer

Turkey: Prolidase activity may, in part, play a role in the pathogenesis of prostate cancer, a recent study has shown.

The findings, published online in Urologic Oncology: Seminars and Original Investigations, suggest that increased collagen turnover may occur in patients with prostate cancer. Increased prolidase seems to be related to increased oxidative stress along with decreased antioxidant levels in prostate cancer. Therefore, increased prolidase activity may, in part, play a role in the pathogenesis of prostate cancer.

Prostate cancer (PCa) remains the most frequently diagnosed neoplasm and the third leading cause of cancer-related deaths in men. Increasing evidence has suggested that oxidative stress (OS) is linked with ageing and severe age-related degenerative diseases, including cancer. Excessive production of reactive oxygen species (ROS) increases oxidative stress in the cell and leads to negative consequences such as inflammation, necrosis, and cell death.

The causes of the high incidence of prostate cancer are poorly understood, experimental, epidemiological, and clinical studies, suggest that oxidative stress plays a major role in explaining prostate cancer development and progression.

To control the balance between ROS production and removal, there are a series of protective molecules and systems known as antioxidant defences. Antioxidants which suppress such oxidative damage play critical roles in aerobic organisms. They prevent free radical-induced damage by preventing ROS formation, scavenging them, or promoting their decomposition. These include enzymes such as superoxide dismutase (SOD), Catalase (CAT), glutathione peroxidase (GPx), some vitamins, and metals.

Glutathione-S transferase (GST) is critical for detoxification. Also, glutathion (GSH) is a protector against oxidative stress. Prolidase is an expressed metallopeptidase that is uniquely needed for the breakdown of proline-rich substrates including collagen.

Against the above background, Mehmet Kaba, Department of Urology, Private Yuzyil Gebze Hospital, Kocaeli, Turkey, and colleagues aimed to identify serum prolidase activity, antioxidant enzyme levels, and oxidative stress in patients with prostate cancers and to evaluate their relationships with each other.

The study included 34 male patients with prostate cancer and with a mean age of 64.2 ± 4.4 years. The control group of 36 male patients (mean age 61.2 ± 3.4) was randomly selected among the volunteers.

Serum samples for measurements of glutathione peroxidase (GPx), superoxide dismutase, malondialdehyde (MDA), catalase, glutathione, and prolidase levels were kept at −20°C until their use.

The researchers revealed significantly higher serum prolidase activity and MDA levels in prostate cancer patients than in controls, while SOD, GPx, and CAT levels were significantly lower.

“Our results suggest that increased prolidase seems to be related to increased oxidative stress along with decreased antioxidant levels in prostate cancer,” the researchers concluded.

Reference:

Kaba, M., Pirincci, N., Demir, H., & Verep, S. (2024). Serum prolidase activity, oxidative stress, and antioxidant enzyme levels in patients with prostate cancer. Urologic Oncology: Seminars and Original Investigations. https://doi.org/10.1016/j.urolonc.2024.01.007

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Family-focused dietary intervention based on traditional diet can reduce risk of incident Metabolic syndrome

Family-focused dietary intervention based on a traditional diet can reduce the risk of incident Metabolic syndrome suggests a new study published in the JAMA Network Open.

The universal call to action for healthier and more sustainable dietary choices is the United Nations’s Sustainable Development Goals framework. The Atlantic diet, originating from the northwest of the Iberian Peninsula, represents an example of a traditional diet that aligns with these principles. A study was done to explore a 6-month intervention based on the Atlantic diet’s effects on metabolic and environmental health, assessing metabolic syndrome (MetS) incidence and the carbon footprint. The Galician Atlantic Diet study was a 6-month randomized clinical trial designed to assess the effects of this regional traditional diet on families’ eating habits. The study was conducted from March 3, 2014, to May 29, 2015, at a local primary health care centre in the rural town of A Estrada in northwestern Spain and involved a multisectoral collaboration. Families were randomly selected from National Health System records and randomized 1:1 to an intervention or control group. This secondary analysis of the trial findings was performed between March 24, 2021, and November 7, 2023. Over 6 months, families in the intervention group received educational sessions, cooking classes, written supporting material, and foods characteristic of the Atlantic diet. In contrast, those randomized to the control group continued with their habitual lifestyle. The main outcomes were MetS incidence, defined per National Cholesterol Education Program Adult Treatment Panel III guidelines, and carbon footprint emissions as an environmental metric using life cycle assessment with daily dietary intake as the functional unit. Results Initially, 250 families were randomized (574 participants; mean [SD] age, 46.8 [15.7] years; 231 males [40.2%] and 343 females [59.8%]). The intervention group included 126 families (287 participants) and the control group, 124 families (287 participants). Ultimately, 231 families completed the trial. The intervention significantly reduced the risk of incident cases of MetS (rate ratio, 0.32; 95% CI, 0.13-0.79) and had fewer MetS components (proportional odds ratio, 0.58; 95% CI, 0.42-0.82) compared with the control condition. The intervention group did not have a significantly reduced environmental impact regarding carbon footprint emissions compared with the control group (−0.17 [95% CI, −0.46 to 0.12] kg CO2 equivalents/person/d). These findings provide important evidence that a family-focused dietary intervention based on a traditional diet can reduce the risk of incident MetS. Further research is needed to understand the underlying mechanisms and determine the generalizability to other populations, taking into account regional cultural and dietary variations

Reference:

Cambeses-Franco C, Gude F, Benítez-Estévez AJ, et al. Traditional Atlantic Diet and Its Effect on Health and the Environment: A Secondary Analysis of the GALIAT Cluster Randomized Clinical Trial. JAMA Netw Open. 2024;7(2):e2354473. doi:10.1001/jamanetworkopen.2023.54473

Keywords:

Family-focused, dietary intervention, traditional diet, incident Metabolic syndrome, Cambeses-Franco C, Gude F, Benítez-Estévez AJ, JAMA network Open

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Neuropathic Pain Worsens Disease Severity in Psoriatic Arthritis Patients

In a recent study published in the Frontiers in Medicine underscore the significant impact of neuropathic pain (NP) on disease activity assessment in patients with psoriatic arthritis (PsA). 

This study was conducted as a cross-sectional analysis which involved a total of 246 PsA patients and excluded the individuals with prior diagnoses of fibromyalgia, depression, anxiety, diabetes or dyslipidemia under treatment. Utilizing the painDETECT questionnaire Esther Toledano and team identified NP in 17.1% of the participants.

The results revealed several correlations in which the patients with NP showed higher levels of leptin. Leptin is commonly associated with obesity which indicates a potential link between NP and metabolic health. Also, poor sleep quality was significantly associated with NP that suggests a bidirectional relationship between sleep disturbances and neuropathic pain.

Fatigue levels were markedly higher in patients with NP when compared to those without by indicating the debilitating impact of NP on daily functioning. NP was found to be correlated with worse disease activity as measured by the clinical Disease Activity Index for Psoriatic Arthritis (cDAPSA) by highlighting the need for comprehensive pain management strategies in PsA patients.

This study emphasized the importance of recognizing and addressing NP in PsA management by underscoring the complex relationship between pain, comorbidities and disease severity in Psoriatic Arthritis patients. This research provides valuable insights into the multifaceted nature of pain in PsA and calls for an inclusive approach to patient care. Addressing neuropathic pain and its related factors will help healthcare providers to potentially enhance the quality of life and overall outcomes for individuals with Psoriatic Arthritis.

Source: 

Toledano, E., Queiro, R., Gómez-Lechón, L., Chacón, C. C., Hidalgo, C., Ibañez, M., Díaz-Álvarez, A., & Montilla, C. (2024). Influence of comorbidities not associated with fibromyalgia on neuropathic pain in patients with psoriatic arthritis: relationship with clinical parameters. In Frontiers in Medicine (Vol. 11). Frontiers Media SA. https://doi.org/10.3389/fmed.2024.1331761

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