European Regulators Back Novo Nordisk's Haemophilia Treatment

Novo Nordisk's stock price surged by 2.83% to $42.89 after European regulators recommended marketing authorisation for its haemophilia A treatment, FREHEMGO.

The Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency backed FREHEMGO, also known as denecimig, for routine preventive treatment in adults and children with or without factor VIII inhibitors.

FREHEMGO is a next-generation factor VIIIa mimetic bispecific antibody designed to reduce bleeding episodes while offering patients several dosing schedules. The medicine can be administered weekly, biweekly, or monthly using a pre-filled pen.

The positive recommendation was based on data from the FRONTIER clinical development programme, which showed that denecimig reduced annualised bleeding rates compared with previous treatments.