EMA CHMP recommends approval of 12 new medicines

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of 12 new medicines and therapeutic extensions for 11 existing ones following its September 2026 meeting.

Key recommendations include ocrelizumab for the intravenous treatment of children and adolescents aged 10 and older with relapsing multiple sclerosis (RMS). Roche noted that a final decision from the European Commission is expected shortly. Other approved therapies include Frehemgo (denecimig) for hemophilia A prophylaxis, Gevalka (ensartinib) for advanced ALK-positive non-small cell lung cancer, and Klygefa (gefurulimab) for generalized myasthenia gravis.

Additional approvals cover various conditions: Lifyorli (relacorilant) and Sepalna (senaparib) for ovarian cancer, Povofortay (povorcitinib) for moderate-to-severe hidradenitis suppurativa, and Zeydovio (glepaglutide) for short bowel syndrome. The committee also recommended the inactivated rabies vaccine VaxRabeo for all age groups and biosimilars Adcomfo (omalizumab) and Pebrilzo (pertuzumab).