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The approval is based on the Phase 3 STELLAR trial, which compared WINREVAIR (n=163) to placebo (n=160), both in combination with background standard of care therapies in adult patients with PAH (WHO Group 1 FC II or III). Results showed adding WINREVAIR to background therapy increased six-minute walk distance from baseline by 41 meters (95% CI: 28, 54; p<0.001; placebo-adjusted) at Week 24 and significantly improved multiple important secondary outcome measures, including reducing the risk of death from any cause or PAH clinical worsening events by 84% versus background therapy alone (number of events: 9 vs 42, hazard ratio=0.16; 95% CI: 0.08, 0.35; p<0.001).

“Healthcare providers should monitor hemoglobin and platelets before each dose of WINREVAIR for the first 5 doses, or longer if values are unstable, and periodically thereafter to determine if dose adjustments are required. WINREVAIR may increase hemoglobin and may lead to erythrocytosis, which if severe may increase the risk of thromboembolic events or hyperviscosity syndrome. WINREVAIR also may decrease platelet count and lead to severe thrombocytopenia, which may increase the risk of bleeding; thrombocytopenia occurred more frequently in patients also receiving prostacyclin infusion. Treatment should not be initiated if platelet count is <50,000/mm³,” the release added.

“The Pulmonary Hypertension Association welcomes the development of new therapies for those with PAH,” said Matt Granato, president and chief executive officer, Pulmonary Hypertension Association. “A diagnosis of PAH is a life-changing experience for patients and families due to its chronic, progressive nature. Patients with PAH experience limiting symptoms such as shortness of breath and fatigue. We are excited to see industry research leading to a better understanding of PAH and the development of a medicine in a novel treatment pathway that expands options for the patient community.”

“New treatment options continue to be needed for patients with pulmonary arterial hypertension that support important clinical goals, including increasing exercise capacity and improving functional class,” said Dr. Aaron Waxman, Executive Director of the Center for Pulmonary Heart Diseases at Brigham and Women’s Hospital and investigator on the Phase 3 STELLAR study. “Sotatercept added to background therapy has the potential to become a new standard of care option for patients with pulmonary arterial hypertension.”

WINREVAIR is given once every three weeks by subcutaneous injection and may be administered by appropriate patients or caregivers with guidance, training and follow-up from a healthcare provider. Healthcare providers and patients/caregivers should refer to the Instructions for Use for information on the proper preparation and administration of WINREVAIR. Merck estimates that WINREVAIR will be available for dispensing by select specialty pharmacies in the U.S. by the end of April.

“PAH remains a debilitating disease with high morbidity and mortality,” said Dr. Eliav Barr, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “This approval of WINREVAIR is an important milestone and a testament to our science-led strategy and focus on the development of innovations that can help people affected by rare diseases like PAH. We are proud to bring this novel medicine to patients.”

The primary efficacy endpoint in the STELLAR trial was the change from baseline at Week 24 in 6-Minute Walk Distance (6MWD). In the WINREVAIR treatment group, the placebo-adjusted median increase in 6MWD was 41 meters (95% CI: 28, 54; p<0.001, Hodges-Lehmann estimate). Additionally, patients who added WINREVAIR had statistically significantly greater improvements compared to placebo across multiple secondary endpoints:

• Treatment with WINREVAIR led to an improvement in FC from baseline at Week 24 in 29% of patients compared to 14% of patients treated with placebo (p<0.001).
• Treatment with WINREVAIR resulted in an 84% reduction in the occurrence of death or PAH clinical worsening events compared to placebo (median duration of exposure 33.6 weeks; number of events: 9/163 vs 42/160, hazard ratio=0.16; 95% CI: 0.08, 0.35; p<0.001).
• Treatment with WINREVAIR led to an improvement from baseline in pulmonary vascular resistance (PVR). The median treatment difference in PVR between WINREVAIR and placebo was -235 dynes*sec/cm5 (95% CI: -288, -181; p<0.001).
• Treatment with WINREVAIR led to an improvement from baseline in N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels. The median treatment difference in NT-proBNP between WINREVAIR and placebo was -442 pg/mL (95% CI: -574, -310; p<0.001).

The STELLAR study (NCT04576988) was a global, double-blind, placebo-controlled, multicenter, parallel-group clinical trial in which 323 patients with PAH (WHO Group 1 FC II or III) were randomized 1:1 to WINREVAIR (target dose 0.7 mg/kg) (n=163) or placebo (n=160) plus stable background therapy administered subcutaneously once every 3 weeks.

The most common PAH etiologies were idiopathic PAH (59%), heritable PAH (18%), and PAH associated with connective tissue diseases (CTD) (15%). Most participants were receiving either three (61%) or two (35%) background drugs for PAH, and 40% were receiving prostacyclin infusions. The mean time from PAH diagnosis was 8.8 years. Patients had a WHO FC II (49%) or III (51%) at baseline.

WINREVAIR is FDA-approved for the treatment of adults with pulmonary arterial hypertension (PAH, WHO Group 1) to increase exercise capacity, improve WHO functional class (FC) and reduce the risk of clinical worsening events. WINREVAIR is the first activin signaling inhibitor therapy approved to treat PAH. WINREVAIR improves the balance between pro-proliferative and anti-proliferative signaling to modulate vascular proliferation. In preclinical models, WINREVAIR induced cellular changes that were associated with thinner vessel walls, partial reversal of right ventricular remodeling, and improved hemodynamics.

WINREVAIR is the subject of a licensing agreement with Bristol Myers Squibb.

Patna: The demolition of the entire frontal structure of the more than 90-year-old Women Hospital at the iconic Patna Medical College and Hospital (PMCH) has stirred anguish among heritage enthusiasts and former students of the esteemed institution. 

The PMCH was established in 1925 as Bihar and Orissa province’s first medical college, it holds significant historical importance, having been founded in the early years following the region’s separation from the Bengal Presidency in 1912.

On March 22, coinciding with the 112th anniversary of Bihar’s modern statehood, laborers were observed dismantling the remaining frontal structures of the Women Hospital building situated within the PMCH campus along the historic Ashok Rajpath.

Officials said a segment of the front portion of the Women Hospital building has been demolished to make way for infrastructure projects. They said the demolition work started earlier this month, news agency PTI reported.

Chief Minister Nitish Kumar on February 27 inaugurated the first phase of the PMCH redevelopment project.

As part of the mega infrastructure revamp plan, a 5,462-bed hospital complex will come up at the old PMCH site for Rs 5,540 crore. The project is expected to be completed in seven years. The foundation stone of the mega project was laid by Kumar on February 8, 2021.

The ongoing redevelopment initiative, which began with the demolition of select structures in 2021 to make room for modern high-rise facilities, aims to revitalize the PMCH campus, originally established as the Prince of Wales Medical College in 1925.

This was Bihar and Orissa province’s first medical college. The college, renamed PMCH after Independence, was in turn born out of the Temple Medical School, established in 1874 in Bankipore.

Bihar and Orissa as a separate province was carved out of the Bengal presidency in 1912, with the capital at Patna. On April 1, 1936, Orissa (now Odisha) became a separate state.

Bihar government celebrates March 22 as Bihar Diwas, marking the formation of the state.

Several old buildings of PMCH, including the old medical superintendent’s bungalow, prison ward, and nurses hostel, have been demolished as part of the revamp project. Its alumni had earlier made a fervent appeal to the authorities to spare the core heritage structures which tell the stories of the famed institution’s inception.

According to PTI, PMCH Alumni Association president Satyajeet Kumar Singh reiterated his appeal to at least spare the historic old Bankipore General Hospital building and Administrative Block to “let future generations see the legacy of the institution in a tangible form”.

The partial demolition of the Women’s Hospital, set up in 1930, has also sparked an outcry among heritage lovers.

Aman Lal, 20, a student of Patna College said, “The government is slowly dismantling all key heritage buildings of the city which gave our state and Patna its identity.”

“On Bihar Diwas I was on my way to college when I saw labourers pulling down the remnants of the front portion of the iconic Women’s Hospital building. It broke my heart. Instead of celebrating our built heritage on Bihar Diwas, the government razed it. It’s a shame,” he said.

Prateek Nishant, a PMCH alumnus whose great grandfather, Tarini Prasad Sinha, was among the first graduating batch in 1927, said, “Heritage and development can co-exist and it needs sensitive planning”.

“As a former student, I feel sad. The heritage buildings of PMCH, which turns 100 next year, should have been saved for posterity. The new blocks of PMCH should have been built elsewhere in the city,” he said.

Phase one of the redevelopment project includes a G+9 multi-utility building, housing the OPD, blood banks, surgical store, medical store, blood bank, among other facilities, the senior official said.

Partial demolition of the Women Hospital has been carried out to also accommodate the alignment of an under-construction double-decker flyover along a section of the Ashok Rajpath from Kargil Chowk to NIT More, the official said.

Many educational and other institutions located along the Ashok Rajpath have been heavily impacted due to the double-decker flyover project and the ongoing construction of a corridor of Patna Metro.

The foundation stone of the little over 2 km flyover was laid on September 4, 2021, by the chief minister.

While PMCH’s main gate has been closed since July 2022 for the construction of a metro station, a significant portion of the front of the historic cancer ward building was demolished by early 2023 to build the metro corridor.

In September 2022, official sources told PTI that the old Women Hospital of the PMCH shall not be affected by the revised alignment of the Patna Metro along Ashok Rajpath.