CHMP Backs 12 New Medicines, Including First Oral Daily Hidradenitis Suppurativa Option and Earlier-Line Tecvayli
核心洞察
The EMA's CHMP recommended 12 new medicines for approval at its September 14-17, 2026 meeting, alongside 11 therapeutic indication extensions and two biosimilars.
Povofortay (povorcitinib) became the first oral daily treatment recommended for adults with moderate to severe hidradenitis suppurativa (搜索) refractory or intolerant to anti-TNF therapy.
Johnson & Johnson's Tecvayli (teclistamab) won support for earlier-line multiple myeloma (搜索) use, with MajesTEC-3 data showing a 71% reduction in progression risk versus standard of care.
The European Medicines Agency (搜索)'s Committee for Medicinal Products for Human Use recommended 12 new medicines for marketing authorisation at its September 14-17, 2026 meeting, and adopted positive opinions on extensions of therapeutic indication for 11 already-authorised products. The recommendations now pass to the European Commission, which is expected to issue decisions within approximately two months under the standard regulatory timeline.
Tecvayli Moves Into Earlier Lines of Multiple Myeloma
Among the most consequential decisions, the CHMP backed earlier-line use of Johnson & Johnson's Tecvayli (teclistamab) in multiple myeloma (搜索), broadening eligibility to patients who have received at least one prior therapy. The expansion is supported by data from the MajesTEC-3 trial, which evaluated teclistamab as a monotherapy in patients who had received between one and three prior lines of therapy. According to Johnson & Johnson, the drug demonstrated a 71% reduction in the risk of disease progression compared with standard of care.
A separate CHMP positive opinion issued in June 2026 had already advanced teclistamab in combination with daratumumab, and the European Commission subsequently approved that combination in August 2026. The monotherapy expansion now awaits its own EC decision.
First Oral Daily Option for Hidradenitis Suppurativa
Povofortay (povorcitinib), from Incyte Biosciences Distribution B.V., received a positive opinion for active moderate to severe hidradenitis suppurativa (搜索), also known as acne inversa, in adults. The EMA described Povofortay as the first oral daily treatment that can be prescribed in adults refractory or intolerant to anti-tumour necrosis factor therapy. Acne inversa is a chronic inflammatory skin disease that causes lumps, abscesses and scarring.
Oncology and Rare Disease Recommendations
Gevalka (ensartinib), from SFL Pharmaceuticals Deutschland GmbH, was recommended for adult patients with anaplastic lymphoma kinase positive advanced non-small cell lung cancer (搜索). Lifyorli (relacorilant), from Corcept Therapeutics Netherlands B.V. (搜索), received a positive opinion for platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer, in combination with nab-paclitaxel. Sepalna (senaparib), also from SFL Pharmaceuticals Deutschland GmbH, was recommended as maintenance treatment for advanced epithelial high-grade ovarian, fallopian tube or primary peritoneal cancer.
In haematology, Frehemgo (denecimig), from Novo Nordisk A/S, was recommended for prophylaxis of bleeding episodes in patients with haemophilia A (搜索), an inherited bleeding disorder caused by a lack of factor VIII (搜索). Zeydovio (glepaglutide) was recommended for short bowel syndrome (搜索), in which nutrients and fluids are not properly absorbed by the gut, usually because a large part of the intestine has been surgically removed.
Klygefa (gefurulimab), from Alexion Europe (搜索), was recommended for adult patients with generalised myasthenia gravis (搜索), a disease that leads to muscle weakness and tiredness. The committee also recommended VaxRabeo, a rabies virus (inactivated) strain WISTAR vaccine, for pre-exposure and post-exposure prophylaxis against rabies in individuals of all age groups.
Biosimilars and Generics
Two biosimilars received positive opinions. Adcomfo (omalizumab), from Advanz Pharma Limited, was recommended for asthma, chronic rhinosinusitis with nasal polyps and chronic spontaneous urticaria. Pebrilzo (pertuzumab), from Biosimilar Collaborations Ireland Limited, was recommended for breast cancer in adults and is the first biosimilar medicine recommended for approval following the tailored clinical approach.
Two generics were also backed: Inijaq (tofacitinib) from Gedeon Richter Plc. for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and ulcerative colitis in adults, and juvenile idiopathic arthritis in children from two years of age; and Ruxolitinib Zentiva (ruxolitinib) from Zentiva k.s. for myelofibrosis, polycythaemia vera and graft-versus-host disease.
Indication Extensions
The CHMP adopted a positive opinion to lower the age of administration for Anzupgo (delgocitinib), used for moderate to severe chronic hand eczema in adults, to adolescents 12 years of age and older. Extensions of indication were also recommended for 10 authorised medicines: Abiraterone Mylan, Cosentyx (secukinumab), Enhertu (trastuzumab deruxtecan), Jyseleca (filgotinib), Keytruda (pembrolizumab), Ocrevus (ocrelizumab), Padcev (enfortumab vedotin), Pepaxti (melphalan flufenamide), Sogroya (somapacitan) and Tecvayli. All remain pending EC decisions.
Withdrawals and Re-examinations
Two applications for initial marketing authorisation were withdrawn: Isembyld (apitegromab) from Scholar Rock Netherlands B.V. (搜索) for 5q spinal muscular atrophy (搜索), a genetic disease causing weakness and wasting of muscles including the lung muscles; and Zinmyleo (trilaciclib) from Pharmacosmos A/S for reducing chemotherapy-induced myelosuppression in patients undergoing certain treatment for extensive-stage small-cell lung cancer.
Three indication-extension applications were also withdrawn: Alhemo (concizumab) from Novo Nordisk for use in children below 12 years of age with haemophilia A (搜索) or haemophilia B, with or without factor VIII (搜索) or IX inhibitors; and Vertex Pharmaceuticals (Ireland) Limited's Kaftrio (ivacaftor/tezacaftor/elexacaftor) and Kalydeco (ivacaftor) for children aged one year and older with cystic fibrosis (搜索).
Applicants for Kemsu (sufentanil/ketamine) from Proveca Pharma Limited, Meplyffa (arimoclomol) from Zevra Denmark A/S (搜索), and Qezzaqar (catequentinib) from CATS Consultants GmbH (搜索) for synovial sarcoma or leiomyosarcoma requested re-examination of negative opinions issued in July 2026. The KemSu re-examination follows Proveca's earlier request after the initial negative opinion.
Separately, following a re-examination, the committee confirmed its recommendation to refuse marketing authorisation for Xervyteg (allogeneic faecal microbiota, pooled), intended for the treatment of acute graft-versus-host disease (搜索), a serious, life-threatening condition in which donor cells from a bone marrow or stem cell transplant attack the host body shortly after transplant.
Referral Outcomes
The CHMP finalised its review of medicines containing ipidacrine, used in adults for various conditions affecting the nervous system, recommending several changes including restricting and better defining approved uses to align them with available data and current standard of care. The committee also concluded that the benefits of sodium oxybate syrup and oral solution (175 mg/ml) continue to outweigh their risks in treating acute alcohol withdrawal syndrome and supporting long-term abstinence in people with alcohol dependency, though additional studies are required to further characterise efficacy in these uses.