As BioMarin Stumbles, Sanofi Gets Breakthrough Status For Hemlibra Challenger

US Filing Expected Shortly

Sanofi and its partner Sobi believe they have the future “Factor VIII of choice” t could also challenge the dominance of Roche’s Hemlibra.

Sanofi_Berlin
Sanofi has made rare blood disorders one of its targeted key growth drivers. • Source: Shutterstock

Sanofi has received a US breakthrough therapy designation for its hemophilia A Factor VIII candidate efanesoctocog alfa, further enhancing its challenge to the dominance of Roche’s blockbuster, Hemlibra (emicizumab).

The boost from the US Food and Drug Administration on 1 June was based on Phase III trial unveiled in March that showed the drug achieved a mean annualized bleeding

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