Novo Nordisk A/SEMA panel recommended approval of Frehemgo for hemophilia A, advancing Novo's treatment toward EU commercialization.

A European Medicines Agency panel has recommended approval of Frehemgo, Novo Nordisk's injectable treatment for hemophilia A, moving the Danish drugmaker closer to another commercial opportunity outside its diabetes and obesity franchise. The recommendation covers adults and children, including patients with or without inhibitors, and follows results from Novo's FRONTIER clinical program, in which Frehemgo reduced annualized bleeding rates compared with previous clotting-factor preventive treatments and therapies given when bleeding occurred. Novo plans to sell Frehemgo in a single-use, prefilled pen with dosing options ranging from once weekly to once monthly, offering patients more flexibility. The European Commission still needs to give final approval, but Novo is already preparing for commercialization and expects to introduce Frehemgo in a selected European market during the fourth quarter, followed by a broader European Union rollout early next year. The next catalyst is European Commission approval and whether Novo can begin that first launch before year-end.
Novo Nordisk A/SEMA panel recommended approval of Frehemgo for hemophilia A, advancing Novo's treatment toward EU commercialization.