U.S. FDA Approves Update to the Label for WINREVAIR™ (sotatercept-csrk) to Include Data from the Phase 3 HYPERION Trial Evaluating Adults Recently Diagnosed with Pulmonary Arterial Hypertension (PAH, WHO* Group 1 Pulmonary Hypertension)

In HYPERION, in patients diagnosed with PAH in the last 12 months, adding WINREVAIR on top of background therapy reduced the risk of clinical worsening events compared to placebo, informing the use of WINREVAIR earlier in the treatment journey Newly published European Respiratory Society (ERS) clinical guidelines provide updated evidence-based recommendations for the treatment of PAH RAHWAY, N.J., September 22, 2026--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has approved an update to the U.S. product label for WINREVAIR™ (sotatercept-csrk) for injection, 45mg, 60mg, based on the Phase 3 HYPERION trial.