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Merck Presents P-III (HYPERION) Trial Data of Winrevair (sotatercept-csrk) for Pulmonary Arterial Hypertension at ERS 2025

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  • The P-III (HYPERION) trial assessed Winrevair vs PBO, both with background therapy in recently diagnosed adults (n=320) with PAH (WHO Group 1) FC II or III at intermediate or high risk of disease progression
  • Trial showed 76% reduction in clinical worsening, where 10.6% vs 36.9% pts experienced ≥1 event, with treatment benefit seen in 6wks. across all subgroups, incl. idiopathic & CTD PAH, pts on double/triple therapy, & those at intermediate/intermediate-low risk by REVEAL Lite 2 & COMPERA 2.0
  • Winrevair improved 2EPs with 29.4% vs 14.6% achieving multicomponent improvement & 60.1% vs 47.9% maintaining or achieving low REVEAL Lite 2 score (≤5) at Wk. 24, while other measures, incl. 6MWD, NT-proBNP, & WHO FC, showed numerical benefits; low SFRS risk was not significant; published in The NEJMshared with global health authorities

Ref: Merck  | Image: Merck | Press Release

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