Novo Nordisk receives positive European opinion for hemophilia treatment

Novo Nordisk ($NVO) received a positive recommendation from the European Medicines Agency’s human medicines committee for FREHEMGO, its denecimig treatment for hemophilia A. The proposed indication covers adults and children, including patients with and without inhibitors. The medicine would be delivered by a prefilled pen under the skin, with weekly, every-two-week or monthly dosing options.

The recommendation draws on the FRONTIER development program, which showed reductions in bleeding compared with patients’ previous treatment regimens. Novo plans initial European launches in the fourth quarter of 2026, followed by broader availability in 2027, subject to the remaining approval process. A positive committee opinion is an important regulatory step, but it is not the European Commission’s final marketing authorization or confirmation that commercial sales have begun.

Sources:

• Novo Nordisk — CHMP recommendation, company release reprint