Novo's haemophilia drug gets EU approval
NVO•NVO•NVO•NVO•The European Commission approved Novo Nordisk’s Frehemgo to prevent or reduce bleeding episodes in adults and children with haemophilia A. Novo plans to launch it in the first European countries over the next year.
The European Commission approved Frehemgo for adults and children with haemophilia A, with or without inhibitors. The under-the-skin antibody mimics the activity of factor VIII, and patients can choose once-monthly, once-every-two-weeks or once-weekly dosing, Novo said.
Novo said the approval is based on its clinical trial program. In one study, the drug significantly reduced annual bleeding rates compared with prior preventive and on-demand treatments. Novo plans to launch Frehemgo in the first European countries over the next year.
In October, the US Food and Drug Administration extended its review of the drug because of ongoing remediation work at a manufacturing facility.
