Merck Says FDA Approves Update To US Product Label For WINREVAIR For Injection, 45mg, 60mg, Based On The Phase 3 HYPERION Trial

Merck (NYSE: MRK) announced that the FDA has approved an update to the product label for WINREVAIR (sotatercept-csrk) for injection, based on results from the Phase 3 HYPERION trial. The trial demonstrated that adding WINREVAIR to background therapy reduced the risk of clinical worsening events by 76% in adults with pulmonary arterial hypertension (PAH) compared to placebo. The updated label now includes efficacy and safety data for adults diagnosed with PAH within the last 12 months, highlighting the drug's role in early treatment.