Shots:
- The EC has approved Agios’ Pyrukynd(mitapivat), marketed as Aqvesme in the US, for the treatment of anemia in adults with non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia
- Approval was based on the global P-III (ENERGIZE) and (ENERGIZE-T) studies assessing Pyrukynd (100mg, BID) vs PBO in 194 on-transfusion-dependent pts and 258 transfusion-dependent pts, respectively
- Pyrukynd will be commercialized by Avanzanite in the EU under an exclusive agreement with Agios, covering commercialization & distribution across the EEA, the UK, & Switzerland
Ref: Agios | Image: Agios | Press Release
Related News: Agios Reports the US FDA Approval of Aqvesme for Anemia in Alpha or Beta Thalassemia
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