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EMA’s human medicines committee (CHMP) recommended 12 medicines for approval at its September 2026 meeting.
The committee recommended granting a marketing authorisation for Frehemgo (denecimig), for the prophylaxis of bleeding episodes in patients with haemophilia A, an inherited bleeding disorder caused by a lack of factor VIII, a protein that helps blood clot.
Gevalka (ensartinib) received a positive opinion from the CHMP for the treatment of adult patients with anaplastic lymphoma kinase positive advanced non-small cell lung cancer.
The CHMP recommended granting a marketing authorisation for Klygefa (gefurulimab) for the treatment of adult patients with generalised myasthenia gravis, a disease that leads to muscle weakness and tiredness.
The committee adopted a positive opinion for Lifyorli (relacorilant), for the treatment of platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Povofortay (povorcitinib) received a positive opinion from the CHMP for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults. Acne inversa is a chronic inflammatory skin disease that causes lumps, abscesses (collections of pus) and scarring on the skin. Povofortay is the first oral daily treatment that can be prescribed in adults patients refractory or intolerant to anti-tumour necrosis factor therapy.
The CHMP recommended granting a marketing authorisation for Sepalna (senaparib), a maintenance treatment of advanced epithelial high-grade ovarian, fallopian tube or primary peritoneal cancer.
The committee recommended granting a marketing authorisation for VaxRabeo (rabies virus (inactivated) strain WISTAR (PM/WI38 1503-3M)), a vaccine for pre-exposure and post-exposure prophylaxis against rabies in individuals of all age groups. Rabies is a rare but very serious infection caused by a virus which is usually spread through the bite or scratch of an infected animal.
Zeydovio (glepaglutide) received a positive opinion from the CHMP for the treatment of short bowel syndrome, a condition in which nutrients and fluids are not properly absorbed by the gut, usually because a large part of the intestine has been surgically removed.
The committee adopted positive opinions for two biosimilar medicines:
Two generic medicines received a positive opinion:
The CHMP adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Anzupgo, a medicine used to treat moderate to severe chronic hand eczema in adults. The committee recommended lowering the age of administration to adolescents 12 years of age and older.
The committee recommended extensions of indication for another 10 medicines that are already authorised in the European Union (EU): Abiraterone Mylan, Cosentyx, Enhertu, Jyseleca, Keytruda, Ocrevus, Padcev, Pepaxti, Sogroya, and Tecvayli.
Two applications for initial marketing authorisation were withdrawn:
Applications for an extension of the indications of three medicines that are already authorised in the EU were withdrawn:
Question-and-answer documents on the withdrawal of these applications are available in the grid below.
The applicants of Kemsu (sufentanil / ketamine), Meplyffa (arimoclomol) and Qezzaqar (catequentinib) have requested a re-examination of the negative opinions that were issued in July 2026.
Upon receipt of the grounds of these requests, the CHMP will re-examine these opinions and issue final recommendations.
Following a re-examination of its initial opinion, the committee has confirmed its recommendation to refuse marketing authorisation for the medicine Xervyteg (allogeneic faecal microbiota, pooled). The medicine was intended for the treatment of acute graft-versus-host disease (aGvHD), a serious, life-threatening condition where the donor cells of a bone marrow or stem cell transplant attack the host body shortly after the transplant.
For more information, see the question-and-answer document in the grid below.
The CHMP has finalised its review of medicines containing ipidacrine, which are used in adults to treat different conditions affecting the nervous system. The committee recommended several changes, including restricting and better defining the approved uses of the medicine. The aim of the recommendations was to align uses to the available data and the current standard of care. Following a review, the committee also concluded that the benefits of sodium oxybate syrup and oral solution (175 mg/ml) continue to outweigh their risks when used to treat acute alcohol withdrawal syndrome and to support long term abstinence in people with alcohol dependency. However additional studies are required to further characterise the efficacy of the medicines in these uses.
For more information, see the public health communications in the grid below.
The agenda of the September 2026 CHMP meeting is published on EMA's website. Minutes of the meeting will be published in the coming weeks.
CHMP statistics
Key figures from the September 2026 CHMP meeting are represented in the graphic below.
Key figures from the September 2026 CHMP meeting are represented in the graphic below.
September 2026 statistics - monthly and cumulative figures for CHMP opinions and withdrawn applications:
12 positive opinions on new medicines: 7 new non-orphan medicines, 1 orphan medicines, and 2 biosimilar medicine. Total in 2026: 66
0 negative opinions on new medicines. Total in 2026: 8
12 positive opinions on extensions of therapeutic indication. Total in 2026: 92
2 withdrawn application for new medicine. Total in 2026: 8
denecimig
Novo Nordisk A/S
Treatment of prophylaxis of bleeding episodes in patients with haemophilia A
ensartinib
SFL Pharmaceuticals Deutschland GmbH
The treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC)
gefurulimab
Alexion Europe
Treatment of adult patients with generalised myasthenia gravis (gMG)
relacorilant
Corcept Therapeutics Netherlands B.V
Lifyorli in combination with nab-paclitaxel is indicated for the treatment of adult patients with platinum-resistant high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens
This medicine was designated as an orphan medicine.
povorcitinib
Incyte Biosciences Distribution B.V
Treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults
senaparib
SFL Pharmaceuticals Deutschland GmbH
Maintenance treatment of advanced epithelial high-grade ovarian, fallopian tube or primary peritoneal cancer
Rabies vaccine (inactivated) for human use
Sanofi Winthrop Industrie
Pre-exposure and post-exposure prophylaxis against rabies in all age groups
glepaglutide
Treatment of adults with Short Bowel Syndrome
omalizumab
Advanz Pharma Limited
Treatment of asthma, chronic rhinosinusitis with nasal polyps (CRSwNP) and chronic spontaneous urticaria (CSU)
pertuzumab
Biosimilar Collaborations Ireland Limited
Treatment of breast cancer in adults
tofacitinib
Gedeon Richter Plc.
Treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis in adults, and juvenile idiopathic arthritis (JIA) in children from 2 years old
ruxolitinib
Zentiva k.s.
Treatment of myelofibrosis (MF) in adults, treatment of polycythaemia vera (PV) in adults and treatment of Graft versus host disease (GvHD) in adults and children
sufentanil / ketamine - PUMA
Proveca Pharma Limited
Treatment of acute pain in children aged 1 to less than 18 years
arimoclomol
Zevra Denmark A/S
catequentinib
CATS Consultants GmbH
Treatment of synovial sarcoma or leiomyosarcoma
This medicine was designated as an orphan medicine
Treatment of allogeneic faecal microbiota, pooled
This medicine was designated as an orphan medicine
trilaciclib
Pharmacosmos A/S
apitegromab
Scholar Rock Netherlands B.V.
abiraterone acetate
Mylan Pharmaceuticals Limited
delgocitinib
Leo Pharma A/S
secukinumab
Novartis Europharm Limited
trastuzumab deruxtecan
Daiichi Sankyo Europe GmbH
filgotinib
Alfasigma S.p.A.
pembrolizumab
Merck Sharp & Dohme B.V.
ocrelizumab
Roche Registration GmbH
enfortumab vedotin
Astellas Pharma Europe B.V.
melphalan flufenamide
Oncopeptides AB
somapacitan
Novo Nordisk A/S
teclistamab
Janssen Cilag International
concizumab
Novo Nordisk A/S
ivacaftor / tezacaftor / elexacaftor
Vertex Pharmaceuticals (Ireland) Limited
Ivacaftor
Vertex Pharmaceuticals (Ireland) Limited
ipidacrine
sodium oxybate
dabigatran etexilate
Boehringer Ingelheim International GmbH