MRK · News · 20260922N

Regulatory Approval Milestones

Merck & Co., Inc. · 2026-09-22 · Importance 47 · Surprise 60 · In source text

On September 22, 2026, the U.S. Food and Drug Administration approved an update to Merck’s U.S. WINREVAIR label. The update incorporates data from the Phase 3 HYPERION trial in adults recently diagnosed with pulmonary arterial hypertension (PAH), WHO Group 1 pulmonary hypertension. WINREVAIR is an activin signaling inhibitor marketed with Bristol Myers Squibb and is approved to improve exercise capacity in adults with PAH.

Key facts

• 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. source
• Merck announced that the U.S. FDA approved a label update for Winrevair, its pulmonary arterial hypertension treatment marketed with Bristol Myers Squibb. source
• Japan approved KEYTRUDA QLEX, as referenced alongside a U.S. label update for WINREVAIR. source
• The label update for Winrevair acknowledges the drug's benefits when used earlier in a patient’s treatment. source
• WINREVAIR is FDA-approved for the treatment of adults with pulmonary arterial hypertension (PAH, WHO Group 1 pulmonary hypertension) to improve exercise capacity. source

Impact estimates