Winrevair FDA Approval History
Last updated by Judith Stewart, BPharm on April 2, 2024.
FDA Approved: Yes (First approved March 26, 2024)
Brand name: Winrevair
Generic name: sotatercept
Dosage form: for Injection
Company: Merck
Treatment for: Pulmonary Arterial Hypertension
Winrevair (sotatercept) is an activin signaling inhibitor used for the treatment of adults with pulmonary arterial hypertension.
- Winrevair is indicated 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.
- Pulmonary arterial hypertension (PAH) is a rare and progressive blood vessel disorder characterized by the constriction of small pulmonary arteries and elevated blood pressure in the pulmonary circulation. It is caused by hyperproliferation of cells in the arterial walls in the lung, leading to narrowing and abnormal constriction.
- Winrevair is thought to work by modulating vascular cell proliferation to slow down or reverse the process of pulmonary vascular remodelling that occurs in PAH.
- FDA approval of Winrevair was based on the placebo-controlled Phase 3 STELLAR trial. The primary efficacy endpoint was the change from baseline at Week 24 in 6-Minute Walk Distance (6MWD). Results showed that adding Winrevair to background therapy increased 6MWD from baseline by 41 meters 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.
- Winrevair is administered by subcutaneous injection every 3 weeks.
- Warnings and precautions associated with Winrevair include erythrocytosis, severe thrombocytopenia, serious bleeding, embryo-fetal toxicity, and impaired fertility.
- Common adverse reactions include headache, epistaxis, rash, telangiectasia, diarrhea, dizziness, and erythema.
Development timeline for Winrevair
Further information
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