Germany's Bayer secures U.S. FDA approval for hemophilia A therapy

[March 17, 2016]  (Reuters) - The U.S. Food and Drug Administration approved Bayer AG's therapy for the most common form hemophilia, the company said on Thursday, about three weeks after the treatment was cleared for use in Europe.

The therapy, Kovaltry, is designed to reduce bleeding in patients with hemophilia A when used prophylactically two or three times per week, and was approved by the European Commission on Feb. 22.

Bayer estimates there are currently about 16,000 people living with hemophilia A in the United States.

Due to a fault in a gene that regulates the body's clotting mechanism, people with hemophilia are susceptible to spontaneous bleeding as well as severe bleeding following injury or surgery.

Hemophilia has no cure. Patients typically require frequent, life-long injections of blood clotting proteins that can cost up to $300,000 a year for a single patient.

A Bayer spokeswoman said the company could not specify a price for Kovaltry but added that it had already captured the second-largest share of the hemophilia A market in the United States.

The German drugmaker's established hemophilia A therapy, Kogenate, brought in global sales of about 1.15 billion euros ($1.30 billion) last year.

(Reporting by Natalie Grover in Bengaluru; Editing by Anupama Dwivedi)

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