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 )
.