U.S. FDA Approves Sanofi’s Bleeding Disorder Therapy

The US FDA has approved Sanofi’s therapy, Altuviiio, for hemophilia A, a type of inherited bleeding disorder. Altuviiio is expected to be launched in the US in April and is likely to be one of the best in its class, according to an analyst. The average annual cost of existing clotting factor therapies is approximately $300,000, and Sanofi will price Altuviiio at parity with the annual cost of treating a prophylaxis patient on Eloctate. Altuviiio is expected to compete with other factor replacement therapies, including those from Takeda Pharmaceutical, Bayer, and Novo Nordisk.