U.S. health regulators have approved Sanofi SA’s therapy to treat a type of inherited bleeding disorder known as hemophilia A, the French drugmaker said on Thursday, and it expects to launch it in the United States in April. With Food and Drug Administration approval, Sanofi’s replacement therapy brand Altuviiio is entering a market dominated by rivals such as Shire, Bayer AG and Novo Nordisk, which sell factor replacement therapies that have been the standard treatment for decades.
Factor replacement therapies replace the missing clotting factor so the blood can clot properly by injecting medications into a person’s vein. Sanofi’s drug is likely to be considered one of the best in its class, Morningstar analyst Damien Conover said ahead of the approval.
Barclays analyst Emily Field says “We see peak sales of 2.3 billion euros worldwide”.
The average annual cost of existing coagulation factor therapies is roughly $300,000, and at least two analysts estimated before approval that Sanofi’s drug would cost slightly more than traditional factor-based therapies.
Sanofi, which developed the drug in collaboration with Swedish drugmaker Sobi, said that “the price of Altuviiio will be the same as the annual cost of treating a prophylactic patient with Eloctate (a hemophilia A drug from Biogen Idec).
The FDA approval also provides patients with an alternative to Roche’s successful drug Hemlibra, which is the market leader in this indication.
Field said “I think most doctors think that, at least in the first few years after launch, Altuviiio would only take share from other factor therapies and not from Hemlibra”. Hemophilia A is a genetic disorder caused by missing or defective factor VIII, a clotting protein.
Written by: Vaishali Verma
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