U.S. FDA approves Sanofi's bleeding disorder therapy

By Sriparna Roy and Khushi Mandowara

(Reuters) -The U.S. Food and Drug Administration has approved Sanofi SA's therapy to treat a type of inherited bleeding disorder known as hemophilia A and expects to launch it in the United States in April, the French drugmaker said on Thursday.

Sanofi's replacement therapy – Altuviiio – is entering a market dominated by rivals like Takeda Pharmaceutical, Bayer AG and Novo Nordisk, which sell factor replacement therapies that have been the standard treatment for decades.

Factor replacement therapies replace the missing blood clotting factor so that blood can clot properly by injecting treatment products into a person's vein.

Sanofi's drug is likely to be considered one of the best in that class, said Damien Conover, Morningstar analyst, ahead of the approval.

"We see 2.3 billion euros of peak sales globally," said Barclays analyst Emily Field.

The average annual cost of existing clotting factor therapies is roughly $300,000, and at least two analysts ahead of the approval estimated the price of Sanofi's drug to be slightly at a premium to the traditional factor therapies.

Sanofi, which developed the drug along with Swedish drugmaker Sobi, said it will price Altuviiio at parity to the annual cost of treating a prophylaxis patient on Eloctate.

The French drugmaker gained access to Elocate and Altuviiio through a $11.6-billion buyout of U.S. hemophilia specialist Bioverativ in 2018, which was separated from Biogen Inc.

The FDA approval also provides patients an alternative to Roche's blockbuster drug, Hemlibra, which is the market leader for this indication.

"I think that most doctors are thinking that at least in the first couple of years of the launch Altuviiio would only take share from the other factor therapies and not from Hemlibra," said Field.

Hemophilia A is a genetic disorder caused by missing or defective factor VIII, a clotting protein.

(Reporting by Sriparna Roy and Khushi Mandowara in Bengaluru; Editing by Shinjini Ganguli, Shailesh Kuber and Arun Koyyur)

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