Shots: 

• The CHMP has granted a 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 the 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

Related News:- Merck’s Winrevair (sotatercept-csrk) Receives the US FDA’s Approval for the Treatment of Pulmonary Arterial Hypertension (PAH)

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