FDA approves Merck’s Winrevair

The Food and Drug Administration has approved Merck’s Winrevair (sotatercept-csrk) injection, 45 mg, 60 mg, for the treatment of adults with pulmonary arterial hypertension to increase exercise capacity, improve WHO functional class and reduce the risk of clinical worsening events. 

Winrevair is the first FDA-approved activin signaling inhibitor therapy for PAH, representing a new class of therapy that works by improving the balance between pro- and anti-proliferative signaling to regulate vascular cell proliferation underlying PAH.

“Pulmonary arterial hypertension is a rare, progressive and ultimately life-threatening disease in which blood vessels in the lungs thicken and narrow, causing significant strain on the heart,” said Marc Humbert, professor of medicine and director of the Pulmonary Hypertension Reference Center at the Université Paris-Saclay and investigator on the Phase 3 STELLAR study. “Based on the Phase 3 STELLAR trial, adding Winrevair to background PAH therapy demonstrated significant clinical benefits compared to background PAH therapy alone. This approval is an important milestone, as it offers healthcare providers a novel therapeutic option that targets a new PAH treatment pathway.”

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“The Pulmonary Hypertension Association welcomes the development of new therapies for those with PAH,” said Matt Granato, president and CEO of the 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 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.”

“PAH remains a debilitating disease with high morbidity and mortality,” said Eliav Barr, senior vice president and head of global clinical development, chief medical officer of 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.”

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Merck estimates that Winrevair will be available for dispensing by select specialty pharmacies in the U.S. by the end of April.