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Merck’s Winrevair (Sotatercept) Gains the CHMP’s Positive Opinion to Treat Pulmonary Arterial Hypertension (PAH) 

Shots: 

  • The CHMP has granted positive opinion to Winrevair combined with other therapies to treat PAH. EC’s decision is anticipated in Q3’24, applicable across EU, Iceland, Liechtenstein & Norway 
  • The opinion was based on the P-III (STELLAR) study evaluating the safety & efficacy of Winrevair (target dose 0.7mg/kg; n=163) or PBO (n=160) + stable background therapy in PAH patients (N=323) 
  • Winrevair improved 6-minute walk distance (1EP) as well as reduced the death risk from any cause & PAH clinical worsening events (2EPs). Data was published in the NEJM

Ref: Merck | Image: Merck | Press Release

Related News:- Regeneron’s Ordspono Gains the CHMP’s Positive Opinion to Treat r/r Follicular Lymphoma (FL) or Diffuse Large B-Cell Lymphoma (DLBCL) 

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