Merck...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. (Merck (MSD) Press Release) - Sep 22, 2026 - "Today's approval updates the WINREVAIR label to include efficacy and safety data from the HYPERION trial evaluating adults newly diagnosed with PAH (WHO FC II or III, diagnosed within 12 months of study screening) at intermediate to high risk of disease progression...The ERS guidelines provide a 'strong' recommendation for the use of WINREVAIR in adult patients with PAH on background therapy who have not achieved low-risk status at follow up, including patients at intermediate-low, intermediate-high, or high risk, and grade the certainty of evidence for WINREVAIR for this recommendation as 'high,' out of four possible evidence scores (very low, low, moderate, or high)."
FDA approval • Pulmonary Arterial Hypertension
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