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EMA CHMP and EU Commission medicinal product approvals

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2026-09-30 16:45 UTC → 2026-10-24 08:07 UTC · added removed

EMA CHMP and EU Commission medicinal product recommendations approvals

In September 2026, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the approval of 12 new medicines and therapeutic extensions for 11 existing ones. Among these recommendations was ocrelizumab (marketed as Ocrevus) for the intravenous treatment of children and adolescents aged 10 and older with relapsing multiple sclerosis (RMS). Subsequent details regarding this specific recommendation highlighted that the This decision was based on the phase 3 OPERETTA 2 study, which showed ocrelizumab was “noninferior in relapse control and provided superior suppression of MRI-detected brain lesions in pediatric patients” compared to fingolimod. Roche reported that the treatment reduced the risk of relapses by 48% and showed substantial reductions in brain inflammation, specifically regarding T2 and active T1 lesions. Other recommended therapies included denecimig (Frehemgo) for hemophilia A prophylaxis, ensartinib (Gevalka) for advanced ALK-positive non-small cell lung cancer, and gefurulimab (Klygefa) for generalized myasthenia gravis. A final decision from Additional recommendations covered relacorilant (Lifyorli) and senaparib (Sepalna) for ovarian cancer, povorcitinib (Povofortay) for hidradenitis suppurativa, glepaglutide (Zeydovio) for short bowel syndrome, the rabies vaccine VaxRabeo, and biosimilars omalizumab (Adcomfo) and pertuzumab (Pebrilzo). In October 2026, the European Commission is expected regarding these recommendations. officially approved ocrelizumab for pediatric patients aged 10 and older, aiming to address a therapeutic gap for younger patients who often experience more frequent and severe relapses than adults.

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  1. 2026-10-24 08:07 UTC EMA CHMP and EU Commission medicinal product approvals
  2. 2026-09-30 16:45 UTC EMA CHMP medicinal product recommendations

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