Agios Pharmaceuticals, Inc.
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Novartis’s siRNA for lowering cholesterol was also among the 10 new medicines that the European Medicines Agency this week said should be approved in the EU.
The sponsors of 11 new treatments should learn this week whether the European Medicines Agency will recommend EU marketing approval for their products.
The sponsors of up to seven new drugs or vaccines will find out this week whether their products will soon be approved in the EU. The products include two vaccines from Sanofi and what is possibly the first generic rival to Bayer's Xarelto to be assessed by the European Medicines Agency.
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.