The FDA 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.
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 once-a-week injection, Hympavzi, to prevent or reduce bleeding episodes in hemophilia A or B patients aged 12 and older. Pfizer's 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.