Shots:
- The EC has granted approval to Winrevair (45 & 60mg) combined with other PAH therapies to treat PAH, valid across whole EU as well as Iceland, Liechtenstein & Norway
- Approval was based on the P-III (STELLAR) study evaluating the safety & efficacy of Winrevair (target dose 0.7mg/kg, SC, Q3W; n=163) vs PBO (n=160) + stable background therapy in PAH patients (N=323)
- Winrevair improved the 1EP of 6-minute walk distance of 40.8 meters at 24wks. as well as 2EPs of reducing the death risk from any cause & PAH clinical worsening by 82% (number of events: 7 vs 29)
Ref: Merck | Image: Merck | Press Release
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