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US FDA approves Novo Nordisk's bleeding disorder drug
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US FDA approves Novo Nordisk's bleeding disorder drug
Dec 20, 2024 4:33 PM

Dec 20 (Reuters) - The U.S. Food and Drug Administration

has approved Novo Nordisk's drug for the prevention

or reduction of bleeding episodes in patients with a type of the

blood-clotting disorder hemophilia, the agency said on Friday.

The drug, Alhemo, which is injected subcutaneously, was

approved for patients 12 years and older who have antibodies

against the clotting factor replacement that are given as

treatment.

Novo Nordisk said it expects Alhemo to be available

around February, and it will determine the drug's price then.

As many as 33,000 males in the U.S. are estimated to

have hemophilia, with 80-85% having hemophilia A. About 30% of

hemophilia A patients and 5-15% of those with the B type of

hemophilia develop those antibodies, according to the FDA.

In October, the U.S. health regulator approved Pfizer's ( PFE )

once-a-week injection, Hympavzi, to prevent or reduce

bleeding episodes in hemophilia A or B patients aged 12 and

older. Pfizer's ( PFE ) gene therapy Beqvez is also approved for

hemophilia B.

Other treatments include gene therapies such as those

made by Australia's CSL and BioMarin Pharmaceutical ( BMRN )

.

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