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3 clusters · 24 sources · 33 days · First seen · Last updated

EMA CHMP and EU Commission medicinal product approvals

Overview

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). 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. 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 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.

Entities

Roche · European Medicines Agency · Ocrevus · European Commission · ENGAGe

Timeline

  1. [HEALTH] 2 sources
    European Commission approves Ocrevus for pediatric multiple sclerosis

    The European Commission has authorized Ocrevus (ocrelizumab) for children aged 10 and older with recurrent multiple sclerosis, offering a high-efficacy option to reduce relapses and brain inflammation.

  2. [HEALTH] 2 sources
    EU regulators recommend Ocrevus for pediatric multiple sclerosis

    EU regulators have recommended approving the infusion therapy Ocrevus for children and teens aged 10 and older with relapsing multiple sclerosis following successful phase 3 clinical trials.

  3. [HEALTH] 20 sources
    EMA CHMP recommends approval of 12 new medicines

    The EMA's CHMP has recommended the approval of 12 new medicines, including ocrelizumab for pediatric relapsing multiple sclerosis and several oncology and inflammatory disease treatments.

Sources

actusante.net · bariviva.it · bergamonews.it · cagliarilivetv.it · chiamamicitta.it · doctor33.it · farmaciavirtuale.it · farmacista33.it · ferraratoday.it · gaetanews24.it · gliscomunicati.it · ilfattonisseno.it · laprovinciadivarese.it · mantovauno.it · messinatoday.it · ms-uk.org · neurologylive.com · ocio.diarioinformacion.com · primasaronno.it · quotidianodelsud.it · rifday.it · romasette.it · torrinomedica.it · tunews24.it

This summary has been updated 1 time: see revision history