New bleeding disorder therapy approved by FDA

KARACHI: French drug maker Sanofi’s SASY.PA therapy to treat a type of inherited bleeding disorder, Hemophilia A, has been approved by the US Food and Drug Administration (FDA) and being rated the best among its class.

It is expected to be launched in the United States in April, 2023, the company says.

Sanofi’s replacement therapy – Altuviiio – is entering a market dominated by rivals like Takeda Pharmaceutical (4502.T), Bayer AG (BAYGn.DE) and Novo Nordisk (NOVOb.CO), 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, says Damien Conover, an analyst, ahead of the approval.

“We see 2.3 billion euros of peak sales globally,” says 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.

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