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FDA Approves New Hemophilia Therapy

Bayer AG’s Kovaltry joins a crowded field

The FDA has approved Kovaltry, Bayer AG’s therapy for the most common form of hemophilia, approximately three weeks after it was cleared for use in Europe.

Kovaltry (antihemophilic factor [recombinant]), a prophylactic infusion administered two or three times a week, is indicated for use in adults and children with hemophilia A to reduce the frequency of bleeding episodes. In addition, it may be used for on-demand treatment and control of bleeding episodes or for the perioperative management of bleeding. The therapy is a recombinant, human DNA sequence–derived, full-length factor VIII concentrate, which is reconstituted prior to intravenous use.

Patients with hemophilia have a flaw in a gene responsible for regulating the clotting factor of blood, which makes them susceptible to spontaneous bleeding as well as severe bleeding following injuries or surgery. The disorder has no cure and most patients require regular injections of blood clotting proteins. According to Reuters, these treatments may have an annual cost of $300,000 per patient.

The cost for Kovaltry is currently unavailable, a Bayer spokeswoman told Reuters, but she said that the company had already captured the second-largest share of the hemophilia A market in the United States. Bayer’s Kogenate, another therapy for hemophilia A, had worldwide sales of approximately $1.30 billion last year.

The existing market for hemophilia treatments is flush with therapies, each with their own dosing schedules. Many new treatments are in the pipeline as well, including those from Roche Holding AG and Alnylam Pharmaceuticals, Inc. Convenience and frequency of administration, reports Reuters, may be determining factors for success.

Sources: Reuters; March 17, 2016; and Kovaltry prescribing information.

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