Shots: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 progressionTrial showed 76% reduction in clinical worsening, where 10.6% vs 36.9% pts experienced ≥1 event, with treatment benefit seen in…
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;…
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…

