Novo's haemophilia drug gets EU approval

Nov 13 (Reuters) - Novo Nordisk NOVOb.CO said on Friday the European Commission has granted approval for its treatment to prevent or reduce the frequency of bleeding episodes in adults and children with haemophilia A, a rare blood disorder.

Here are more details:

• The drug, branded Frehemgo, is a next-generation antibody designed to mimic the activity of the blood-clotting protein called factor VIII, according to Novo. It is administered as an under-the-skin injection

• Patients with haemophilia A, with or without inhibitors, can choose between once-monthly, once-every-two-weeks or once-weekly dosing, Novo said

• Haemophilia is a rare genetic bleeding disorder that impairs the body's ability to make blood clots. There are different types of haemophilia, with haemophilia A caused by a missing or defective clotting factor VIII

• The approval is based on results from the clinical trial program testing the drug. In one study, Novo said the drug significantly reduced annual bleeding rates compared with prior preventive and on-demand treatments in people with hemophilia A, with or without inhibitors

• Novo plans to launch Frehemgo in the first European countries over the next year, it said

• The US FDA in October extended its review of the drug due ​to ongoing remediation work at a manufacturing facility ‌