EMA panel backs Novo Nordisk's hemophilia drug Frehemgo

On 17 September, a European Medicines Agency panel recommended the approval of Frehemgo, an injectable treatment for hemophilia A developed by Novo Nordisk.

The positive opinion covers both adult and pediatric patients, including those with or without inhibitors. The panel based its recommendation on data from the FRONTIER clinical program, where Frehemgo reduced annualized bleeding rates compared with prior preventive clotting-factor therapies and on-demand treatments.

Novo Nordisk plans to distribute Frehemgo in a single-use prefilled pen with dosing intervals ranging from once weekly to once monthly. Final marketing authorization remains subject to formal approval by the European Commission.

The company expects to launch the treatment in a selected European market during the fourth quarter, followed by a wider rollout across the European Union early next year. The prospective release offers Novo Nordisk a new commercial avenue outside its core diabetes and obesity portfolio.