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Alnylam Pharmaceuticals and Sanofi Report the US FDA’s Approval of Qfitlia (Fitusiran) to Treat Hemophilia A or B

Shots:

  • The US FDA has approved Qfitlia to treat routine prophylaxis and prevent or reduce the frequency of bleeding episodes in pts. (age≥ 12yrs.) with hemophilia A or B, with or without factor VIII or IX inhibitors. Regulatory submissions have been completed in China & Brazil
  • Qfitlia published clinical data in the NEJM in 2017, showing a reduction in bleeding rates in haemophilia pts. and initiating the P-III development program
  • In 2014, Sanofi gained global rights to co-develop & co-commercialize Qfitlia under a license & collaboration agreement which was later upgraded to full global rights in 2018, while Alnylam became eligible for tiered royalties of 15-30% on global net sales

Ref: Businesswire | Image: Alnylam & Sanofi 

Related News:- Alnylam Pharmaceuticals Reports the US FDA’s Approval of Amvuttra (Vutrisiran) to Treat ATTR Amyloidosis with Cardiomyopathy (ATTR-CM)

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