Winrevair (sotatercept)
OrphanPRIMEAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- sotatercept
- Company
- Merck Sharp & Dohme B.V.
- Status
- Authorised
- Therapeutic area
- Hypertension, Pulmonary
- CHMP opinion
- Thu 27 Jun 2024
- EU approval
- Thu 22 Aug 2024
- Designations
- Orphan, PRIME, Additional monitoring
- Application
- EMEA/H/C/005647
- ATC
- C02KX06
- Official record
- www.ema.europa.eu
Indication
Winrevair, in combination with other pulmonary arterial hypertension (PAH) therapies, is indicated for the treatment of PAH in adult patients with WHO Functional Class (FC) II, III and IV.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.