Treats pulmonary arterial hypertension (PAH, Group 1 pulmonary hypertension). BLA 761363, held by Merck Sharp Dohme. Sotatercept-Csrk.
As of Nov 13, 2026, BLA 761363 (Winrevair), held by Merck Sharp Dohme, was first approved by FDA on Mar 26, 2024, with 7 approved supplements and 0 published complete response letters.
WINREVAIR is indicated for the treatment of adults with pulmonary arterial hypertension (PAH, Group 1 pulmonary hypertension) to improve exercise capacity and World Health Organization (WHO) functional class (FC), and reduce the risk of clinical worsening events including hospitalization for PAH, lung transplantation and death.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 21, 2026 | Supplement 12Efficacy (new indication or use) · Standard review | Approved | |
| Oct 24, 2025 | Supplement 7Efficacy (new indication or use) · Priority review | Approved | |
| Mar 26, 2024 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Winrevair45MG · injectable;injection | Sotatercept-Csrk | Rx |
| Winrevair60MG · injectable;injection | Sotatercept-Csrk | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 21, 2026 | Supplement 17Labeling · Standard review | Approved | |
| Sep 21, 2026 | Supplement 16Labeling · Standard review | Approved | |
| Sep 21, 2026 | Supplement 12Efficacy (new indication or use) · Standard review | Approved | |
| Aug 12, 2026 | Supplement 13Labeling · Standard review | Approved | |
| Mar 25, 2026 | Supplement 10Labeling · Standard review | Approved | |
| Dec 8, 2025 | Supplement 8Labeling · Standard review | Approved | |
| Oct 24, 2025 | Supplement 7Efficacy (new indication or use) · Priority review | Approved | |
| Mar 26, 2024 | Original applicationNew molecular entity · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
