CHMP September 2026 Recommends 12 New Medicines

The CHMP September 2026 meeting concluded with positive opinions for twelve new medicines and extensions of therapeutic indication for eleven more. The new approvals span haemophilia A, ALK-positive lung cancer, generalised myasthenia gravis, ovarian cancer, hidradenitis suppurativa, and short bowel syndrome, alongside two biosimilars and two generics.

Decision type	Outcome
New medicines recommended for approval	12 (8 new, 2 biosimilars, 2 generics)
Extensions of therapeutic indication	11
Initial applications withdrawn	2
Extension applications withdrawn	3
Re-examinations requested	3
Confirmed refusal after re-examination	1

Source: European Medicines Agency, CHMP meeting highlights, 18 September 2026.

CHMP September 2026 approvals

The Committee for Medicinal Products for Human Use (CHMP) assesses human medicines before the European Commission grants a final marketing authorisation. Eight new medicines earned a positive opinion in September, joined by two biosimilars and two generics.

Medicine	INN	Type	Applicant	Indication
Frehemgo	denecimig	New	Novo Nordisk A/S	Prophylaxis of bleeding episodes in haemophilia A
Gevalka	ensartinib	New	SFL Pharmaceuticals Deutschland GmbH	ALK-positive advanced non-small cell lung cancer
Klygefa	gefurulimab	New	Alexion Europe	Generalised myasthenia gravis
Lifyorli	relacorilant	New (orphan)	Corcept Therapeutics Netherlands B.V.	Platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer
Povofortay	povorcitinib	New	Incyte Biosciences Distribution B.V.	Moderate to severe hidradenitis suppurativa
Sepalna	senaparib	New	SFL Pharmaceuticals Deutschland GmbH	Maintenance of advanced ovarian, fallopian tube, or primary peritoneal cancer
VaxRabeo	rabies vaccine (inactivated)	New	Sanofi Winthrop Industrie	Pre-exposure and post-exposure prophylaxis against rabies
Zeydovio	glepaglutide	New	Not disclosed	Short bowel syndrome in adults
Adcomfo	omalizumab	Biosimilar	Advanz Pharma Limited	Asthma, chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria
Pebrilzo	pertuzumab	Biosimilar	Biosimilar Collaborations Ireland Limited	Breast cancer in adults
Inijaq	tofacitinib	Generic	Gedeon Richter Plc.	Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, juvenile idiopathic arthritis
Ruxolitinib Zentiva	ruxolitinib	Generic	Zentiva k.s.	Myelofibrosis, polycythaemia vera, graft-versus-host disease

Source: European Medicines Agency, CHMP meeting highlights, 18 September 2026.

A few of these stand out. Pebrilzo is the first biosimilar recommended for approval following the EMA’s tailored clinical approach, which reduces the clinical package required for well-understood biological medicines. Povofortay is the first oral daily treatment for adults with hidradenitis suppurativa who are refractory or intolerant to anti-TNF therapy. Lifyorli carries an orphan designation.

Extensions of therapeutic indication

The committee also widened the approved use of eleven medicines already authorised in the EU. For Anzupgo, the age of administration was lowered to adolescents aged 12 and older in chronic hand eczema.

Medicine	INN	Marketing authorisation holder
Anzupgo	delgocitinib	Leo Pharma A/S
Abiraterone Mylan	abiraterone acetate	Mylan Pharmaceuticals Limited
Cosentyx	secukinumab	Novartis Europharm Limited
Enhertu	trastuzumab deruxtecan	Daiichi Sankyo Europe GmbH
Jyseleca	filgotinib	Alfasigma S.p.A.
Keytruda	pembrolizumab	Merck Sharp & Dohme B.V.
Ocrevus	ocrelizumab	Roche Registration GmbH
Padcev	enfortumab vedotin	Astellas Pharma Europe B.V.
Pepaxti	melphalan flufenamide	Oncopeptides AB
Sogroya	somapacitan	Novo Nordisk A/S
Tecvayli	teclistamab	Janssen Cilag International

Source: European Medicines Agency, CHMP meeting highlights, 18 September 2026.

Withdrawals and re-examinations

Two initial applications were withdrawn before a decision: Isembyld (apitegromab) for 5q spinal muscular atrophy and Zinmyleo (trilaciclib) for chemotherapy-induced myelosuppression in extensive-stage small-cell lung cancer. Three extension applications were also withdrawn: Alhemo (concizumab), Kaftrio, and Kalydeco.

The applicants of Kemsu, Meplyffa, and Qezzaqar have requested re-examination of the negative opinions issued in July 2026. The committee also confirmed its refusal of Xervyteg (allogeneic faecal microbiota) for acute graft-versus-host disease.

Referral outcomes

The CHMP finalised its review of ipidacrine-containing medicines, restricting and better defining their approved uses to match the available evidence and current standard of care. It also concluded that sodium oxybate syrup and oral solution (175 mg/ml) continue to offer more benefit than risk for acute alcohol withdrawal and long-term abstinence in alcohol dependency, with further studies still required.

Pradaxa (dabigatran etexilate) also featured in the meeting’s other updates, with a European Commission decision still pending.

Source: European Medicines Agency, CHMP meeting highlights 14-17 September 2026.