Bristol/Agios AML’s Idhifa Fails In Phase III, But Approval Seems Secure
Idhifa is already approved in the US for relapsed or refractory AML patients with IDH2 mutations based on Phase I/II complete responses, but did not meet the overall survival endpoint in the Phase III IDHENTIFY.
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Agios’s divestment of its oncology pipeline and commercial operations provided a rare case where all parties appeared satisfied. In many other cases, there are winners and losers.
Agios’ Phase III Data Move It Closer To First Therapy For Rare Anemia
Strong top-line efficacy in pyruvate kinase deficiency patients who don’t receive regular transfusions looks approvable, analysts say, but Agios will await data in regularly transfused patients.
European CHMP Opinions and MAA Updates
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.