CHMP backs 12 new medicines, 11 indication extensions in September sitting
EMA's CHMP recommended 12 new medicines for approval and 11 indication extensions at its 14-17 September 2026 meeting, and upheld one refusal on re-examination.
What this means
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) is the scientific body that reviews new medicines for the EU market and issues positive or negative opinions that the European Commission then translates into formal marketing authorisations. At its September 14-17, 2026 meeting the CHMP issued positive opinions on 12 new medicines and 11 indication extensions, with no negative opinions on new applications. Among the notable positives: Frehemgo (denecimig, Novo Nordisk) for haemophilia A prophylaxis; Gevalka (ensartinib) for ALK-positive NSCLC; Klygefa (gefurulimab, Alexion) for generalised myasthenia gravis; Povofortay (povorcitinib, Incyte) as a first oral daily therapy for moderate-to-severe hidradenitis suppurativa; VaxRabeo (Sanofi) for rabies pre- and post-exposure; Zeydovio (glepaglutide) for short bowel syndrome; and biosimilars Adcomfo (omalizumab) and Pebrilzo (pertuzumab — the first biosimilar approved via CHMP's tailored clinical approach). Two applications were withdrawn during review — Isembyld (apitegromab, Scholar Rock) for SMA and Zinmyleo (trilaciclib) — and the committee confirmed on re-examination its refusal of Xervyteg (pooled allogeneic faecal microbiota) for acute graft-versus-host disease.
From the source
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 September 2026
18 September 2026
12 new medicines recommended for approval; another 11 medicines recommended for extension of their therapeutic indications
NewsHumanMedicines
12 new medicines recommended for approval
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:
• Adcomfo (omalizumab), for the treatment of asthma, chronic rhinosinusitis with nasal polyps and chronic spontaneous urticaria.
• Pebrilzo (pertuzumab), for the treatment of breast cancer in adults. Pebrilzo is the first biosimilar medicine recommended for approval following the tailored clinical approach.
Two generic medicines received a positive opinion:
• Inijaq (tofacitinib), for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and ulcerative colitis in adults, and juvenile idiopathic arthritis in children from two years of age.
• Ruxolitinib Zentiva (ruxolitinib), for the treatment of myelofibrosis in adults, polycythaemia vera in adults, and graft-versus-host disease in adults and children.
Recommendations on extensions of therapeutic indication for 11 medicines
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.
Withdrawal of applications
Two applications for initial marketing authorisation were withdrawn:
• Isembyld (apitegromab), for the treatment of 5q spinal muscular atrophy, a genetic disease that causes weakness and wasting of the muscles including the lung muscles.
• Zinmyleo (trilaciclib), for reducing myelosuppression (damage to the bone marrow) caused by chemotherapy in patients undergoing certain treatment for extensive-stage small-cell lung cancer.
Applications for an extension of the indications of three medicines that are already authorised in the EU were withdrawn:
• Alhemo (concizumab), for use in children below 12 years of age with haemophilia A or haemophilia B, with or without factor VIII or IX inhibitors.
• Kaftrio (ivacaftor/tezacaftor/elexacaftor), for use in children aged one year and older with cystic fibrosis, in combination with ivacaftor.
• Kalydeco (ivacaftor), for use in combination with a medicine containing ivacaftor/tezacaftor/elexacaftor in children aged one year and older with cystic fibrosis.
Question-and-answer documents on the withdrawal of these applications are available in the grid below.
Start of re-examination
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.
Outcome of re-examination
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.
Conclusion of referral
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.
Agenda and minutes
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.
CHMP statistics
Key figures from the September 2026 CHMP meeting are represented in the graphic below.
© European Medicines Agency
CHMP statistics: Text version
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
Positive recommendations on new medicines
Frehemgo
International non-proprietary name (INN) denecimig
Marketing authorisation applicant Novo Nordisk A/S
Therapeutic indication Treatment of prophylaxis of bleeding episodes in patients with haemophilia A
More information Frehemgo : pending EC decision
Gevalka
INN ensartinib
Marketing authorisation applicant SFL Pharmaceuticals Deutschland GmbH
Therapeutic indication The treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC)
More information Gevalka : pending EC decision
Klygefa
INN gefurulimab
Marketing authorisation applicant Alexion Europe
Therapeutic indication Treatment of adult patients with generalised myasthenia gravis (gMG)
More information Klygefa: pending EC decision
Lifyorli
INN relacorilant
Marketing authorisation applicant Corcept Therapeutics Netherlands B.V
Therapeutic indication 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
More information Lifyorli : pending EC decision
Orphan medicine This medicine was designated as an orphan medicine.
Povofortay
INN povorcitinib
Marketing authorisation applicant Incyte Biosciences Distribution B.V
Therapeutic indication Treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults
More information Povofortay : pending EC decision
Sepalna
INN senaparib
Marketing authorisation applicant SFL Pharmaceuticals Deutschland GmbH
Therapeutic indication Maintenance treatment of advanced epithelial high-grade ovarian, fallopian tube or primary peritoneal cancer
More information Sepalna : pending EC decision
VaxRabeo
INN Rabies vaccine (inactivated) for human use
Marketing authorisation applicant Sanofi Winthrop Industrie
Therapeutic indication Pre-exposure and post-exposure prophylaxis against rabies in all age groups
More information VaxRabeo : pending EC decision
Zeydovio
INN glepaglutide
Therapeutic indication Treatment of adults with Short Bowel Syndrome
More information Zeydovio : pending EC decision
Positive recommendation on new biosimilar medicine
Adcomfo
INN omalizumab
Marketing authorisation applicant Advanz Pharma Limited
Therapeutic indication Treatment of asthma, chronic rhinosinusitis with nasal polyps (CRSwNP) and chronic spontaneous urticaria (CSU)
More information Adcomfo : pending EC decision
Pebrilzo
INN pertuzumab
Marketing authorisation applicant Biosimilar Collaborations Ireland Limited
Therapeutic indication Treatment of breast cancer in adults
More information Pebrilzo : pending EC decision
Positive recommendations on new generic medicines
Inijaq
INN tofacitinib
Marketing authorisation applicant Gedeon Richter Plc.
Therapeutic indication Treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis in adults, and juvenile idiopathic arthritis (JIA) in children from 2 years old
More information Inijaq : pending EC decision
Ruxolitinib Zentiva
INN ruxolitinib
Marketing authorisation applicant Zentiva k.s.
Therapeutic indication 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
More information Ruxolitinib Zentiva : pending EC decision
Start of re-examinations
KemSu
INN sufentanil / ketamine - PUMA
Marketing authorisation holder Proveca Pharma Limited
Therapeutic indication Treatment of acute pain in children aged 1 to less than 18 years
More information KemSu : refusal Q&A
Meplyffa
INN arimoclomol
Marketing authorisation holder Zevra Denmark A/S
More information Meplyffa : refusal Q&A
Qezzaqar
INN catequentinib
Marketing authorisation holder CATS Consultants GmbH
Therapeutic indication Treatment of synovial sarcoma or leiomyosarcoma
More information Qezzaqar : refusal Q&A
Orphan medicine This medicine was designated as an orphan medicine
Outcome of re-examination
Xervyteg
Therapeutic indication Treatment of allogeneic faecal microbiota, pooled
More information Xervyteg : refusal Q&A
Orphan medicine This medicine was designated as an orphan medicine
Withdrawal of applications for initial application procedures
Zinmyleo
INN trilaciclib
Market authorisation applicant Pharmacosmos A/S
More information Zinmyleo : Withdrawal
Isembyldt
INN apitegromab
Market authorisation applicant Scholar Rock Netherlands B.V.
More information Isembyldt : Withdrawal
Positive recommendations on extensions of therapeutic indications
Abiraterone Mylan
INN abiraterone acetate
Marketing authorisation holder Mylan Pharmaceuticals Limited
More information Abiraterone Mylan : pending EC decision
Anzupgo
INN delgocitinib
Marketing authorisation holder Leo Pharma A/S
More information Anzupgo : pending EC decision
Cosentyx
INN secukinumab
Marketing authorisation holder Novartis Europharm Limited
More information Cosentyx : pending EC decision
Enhertu
INN trastuzumab deruxtecan
Marketing authorisation holder Daiichi Sankyo Europe GmbH
More information Enhertu : pending EC decision (to be published soon)
Jyseleca
INN filgotinib
Marketing authorisation holder Alfasigma S.p.A.
More information Jyseleca : pending EC decision
Keytruda
INN pembrolizumab
Marketing authorisation holder Merck Sharp & Dohme B.V.
More information Keytruda : pending EC decision
Ocrevus
INN ocrelizumab
Marketing authorisation holder Roche Registration GmbH
More information Ocrevus : pending EC decision
Padcev
INN enfortumab vedotin
Market authorisation holder Astellas Pharma Europe B.V.
More information Padcev : pending EC decision
Pepaxti
INN melphalan flufenamide
Marketing authorisation applicant Oncopeptides AB
More information Pepaxti : pending EC decision
Sogroya
INN somapacitan
Marketing authorisation applicant Novo Nordisk A/S
More information Sogroya : pending EC decision
Tecvayli
INN teclistamab
Marketing authorisation holder Janssen Cilag International
More information Tecvayli : pending EC decision
Withdrawal of applications for recommendations on extensions of indications
Alhemo
INN concizumab
Market authorisation applicant Novo Nordisk A/S
More information Alhemo : Withdrawal
Kaftrio
INN ivacaftor / tezacaftor / elexacaftor
Market authorisation applicant Vertex Pharmaceuticals (Ireland) Limited
More information Kaftrio : Withdrawal
Kalydeco
INN Ivacaftor
Market authorisation applicant Vertex Pharmaceuticals (Ireland) Limited
More information Kalydeco : Withdrawal
Conclusion of Referrals
Ipidacrine-containing medicinal products
INN ipidacrine
More information Ipidacrine-containing medicinal products - referral
News EMA concludes review of ipidacrine-containing medicines
Sodium oxybate syrup and oral solution for alcohol dependence
INN sodium oxybate
More information Sodium oxybate-containing syrup and oral solution for alcohol dependence - referral
News Benefits of sodium oxybate continue to outweigh risks in people with alcohol dependency
Other updates
Pradaxa
INN dabigatran etexilate
Marketing authorisation applicant Boehringer Ingelheim International GmbH
More information Pradaxa : pending EC decision
Please note that not all documents associated with this page are published at the same time. This page is updated with new documents as soon as they become available. Therefore, users are asked to check the page regularly.
Related content
• Committee for Medicinal Products for Human Use (CHMP): 14-17 September 2026
• Committee for Medicinal Products for Human Use (CHMP)
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Related medicine information
• Frehemgo
• Gevalka
• Klygefa
• Lifyorli
• Povofortay
• Sepalna
• VaxRabeo
• Adcomfo
• Pebrilzo
• Inijaq
• Ruxolitinib Zentiva
• KemSu
• Qezzaqar
• Xervyteg
• Abiraterone Mylan
• Anzupgo
• Enhertu
• Jyseleca
• Keytruda
• Ocrevus
• Padcev
• Tecvayli
• Sogroya
• Alhemo
• Kaftrio
• Zinmyleo
• Kalydeco
• Ipidacrine-containing medicinal products - referral
• Meplyffa
Reproduced from EMA News · view original · public domain or open-licensed government work