FDA approves updated WINREVAIR label for HYPERION trial data
Merck said the U.S. FDA approved an update to the U.S. label for WINREVAIR (sotatercept-csrk) for injection (45mg, 60mg) based on Phase 3 HYPERION trial data in adults recently diagnosed with pulmonary arterial hypertension (PAH, WHO Group 1).
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10:45:41 AM UTC
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The FDA approved a U.S. label update for Merck’s WINREVAIR to include Phase 3 HYPERION data in newly diagnosed PAH, where adding WINREVAIR cut risk of clinical worsening by 76% vs placebo.Material DetailsContext by AI AnalystThis is a late-stage validation step, extending WINREVAIR’s positioning wi…
S. S. product label for WINREVAIR™ (sotatercept-csrk) for injection, 45mg and 60mg, based on Phase 3 HYPERION trial data. The company described WINREVAIR as an activ…