FDA adds HYPERION data to Winrevair label for newly diagnosed pulmonary arterial hypertension

The FDA approved an updated Winrevair (sotatercept) label that adds Phase 3 HYPERION data for adults newly diagnosed with pulmonary arterial hypertension who are at intermediate to high risk of progression. In that trial, adding Winrevair to background therapy cut the risk of clinical worsening by 76% versus placebo. Winrevair sales rose 75% to $588 million in the second quarter.

• Clinical worsening risk reduced 76% vs placebo (HR 0.24; 95% CI 0.14-0.41; p<0.0001)
• Population: WHO functional class II or III PAH diagnosed within 12 months
• Winrevair Q2 2026 sales $588M, up 75%