Pharmaceutical Executive March 27, 2024
Don Tracy, Associate Editor

Winrevair is the first FDA-approved activin signaling inhibitor therapy for pulmonary arterial hypertension.

Merck announced that the FDA has approved Winrevair (sotatercept-csrk) to treat adults with pulmonary arterial hypertension (PAH). According to the company, this marks the first time an activin signaling inhibitor therapy, which aims to improve vascular cell proliferation balance, has been cleared for the treatment of PAH. The approval was based on promising results stemming from the Phase III STELLAR trial, showing that Winrevair increased six-minute walk distance from baseline by 41 meters at week 24, also reducing the potential for death by 84% and potential worsening of the condition.1

“Pulmonary arterial hypertension is a rare, progressive and ultimately life-threatening disease in which blood vessels in the...

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