Summary
EMA’s Committee for Medicinal Products for Human Use issued positive opinions for 12 medicines at its 14–17 September 2026 meeting, including a rabies vaccine, two biosimilars and two generics. The recommendations remain subject to European Commission decisions.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued positive opinions for 12 medicines during its 14–17 September 2026 meeting. The recommendations cover treatments and vaccines for conditions including haemophilia A, lung cancer, myasthenia gravis, ovarian cancer, rabies and short bowel syndrome.
The medicine entries on the EMA page are marked as pending European Commission decisions. A CHMP positive opinion is therefore a regulatory recommendation rather than the final EU marketing authorisation.
Medicines receiving positive opinions
The recommended medicines include:
- Frehemgo (denecimig) for preventing bleeding episodes in patients with haemophilia A, an inherited disorder associated with a lack of factor VIII.
- Gevalka (ensartinib) for adults with ALK-positive advanced non-small-cell lung cancer.
- Klygefa (gefurulimab) for adults with generalised myasthenia gravis, which causes muscle weakness and fatigue.
- Lifyorli (relacorilant), in combination with nab-paclitaxel, for adults with platinum-resistant high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer after one to three previous systemic treatment regimens. EMA identifies it as an orphan medicine.
- Povofortay (povorcitinib) for adults with active moderate to severe hidradenitis suppurativa, also called acne inversa. EMA describes it as the first oral daily treatment that can be prescribed for adults who are refractory or intolerant to anti-tumour necrosis factor therapy.
- Sepalna (senaparib) as maintenance treatment for advanced high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer.
- VaxRabeo, an inactivated rabies vaccine for pre-exposure and post-exposure prophylaxis in people of all age groups.
- Zeydovio (glepaglutide) for adults with short bowel syndrome, in which the gut cannot adequately absorb nutrients and fluids.
The CHMP also issued positive opinions for two biosimilar medicines. Adcomfo (omalizumab) was recommended for asthma, chronic rhinosinusitis with nasal polyps and chronic spontaneous urticaria. Pebrilzo (pertuzumab) was recommended for breast cancer in adults and is the first biosimilar medicine recommended for approval through what EMA calls a tailored clinical approach.
Two generic medicines also received positive opinions: Inijaq (tofacitinib) for several inflammatory diseases in adults and for juvenile idiopathic arthritis in children from two years of age, and Ruxolitinib Zentiva (ruxolitinib) for myelofibrosis, polycythaemia vera and graft-versus-host disease in the populations specified by EMA.
Indication changes, withdrawals and reviews
The committee recommended extending the therapeutic indications of 11 medicines already authorised in the European Union. One change concerns Anzupgo (delgocitinib), for which the recommended minimum age would be lowered to 12 years for the treatment of moderate to severe chronic hand eczema. Other medicines included in the indication-extension recommendations are Abiraterone Mylan, Cosentyx, Enhertu, Jyseleca, Keytruda, Ocrevus, Padcev, Pepaxti, Sogroya and Tecvayli.
Two applications for initial marketing authorisation were withdrawn: Isembyld (apitegromab), proposed for 5q spinal muscular atrophy, and Zinmyleo (trilaciclib), proposed to reduce chemotherapy-related myelosuppression in certain patients with extensive-stage small-cell lung cancer. Applications to extend indications for Alhemo, Kaftrio and Kalydeco were also withdrawn.
Applicants for KemSu (sufentanil/ketamine), Meplyffa (arimoclomol) and Qezzaqar (catequentinib) requested re-examinations of negative opinions issued in July 2026. In a separate re-examination, CHMP confirmed its recommendation to refuse marketing authorisation for Xervyteg, an allogeneic faecal microbiota product intended for acute graft-versus-host disease.
The committee also concluded its referral review of medicines containing ipidacrine, recommending restrictions and clearer definitions of their approved uses so they align with available data and current standard of care. For sodium oxybate syrup and oral solution at 175 mg/ml, CHMP concluded that the benefits continue to outweigh the risks for acute alcohol withdrawal syndrome and support of long-term abstinence in people with alcohol dependency, while calling for additional studies to further characterise efficacy in those uses.
The September meeting’s recommendations will proceed through the European Commission decision process. EMA said the meeting minutes would be published in the following weeks.