EMA Committee for Medicinal Products for Human Use – Meeting Highlights – September 2026

18/09/2026 Public health update

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has published the highlights from its meeting held in September 2026.

The CHMP is the European Medicines Agency’s (EMA) scientific committee responsible for evaluating the quality, safety, and efficacy of human medicines. The committee meets once a month and is composed of scientific experts from all 27 EU Member States as well as Iceland, Lichtenstein and Norway. HPRA experts act as the representatives from Ireland.  

The CHMP issues an opinion on whether a medicine should be granted an  EU-wide centralised marketing authorisation (i.e., license). This opinion is based on a rigorous review of scientific and regulatory information to ensure the benefits of taking a medicine outweigh the known and potential risks. It is the European Commission who ultimately grants a centralised marketing authorisation based on the CHMP’s opinion.  

Whether a centrally authorised medicine is marketed (i.e. placed on sale) in Ireland is at the discretion of the company which holds the marketing authorisation. The HPRA and EMA have no role in the marketing or pricing and reimbursement of medicines in Ireland.    

Latest recommendations for approval

Following the September 2026 CHMP meeting, the following medicines received a positive opinion and were recommended for approval. 

New medicines

  • 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) for the treatment of adult patients with anaplastic lymphoma kinase positive advanced non-small cell lung cancer.
  • Klygefa (gefurulimab) for the treatment of adult patients with generalised myasthenia gravis, a disease that leads to muscle weakness and tiredness .
  • Lifyorli (relacorilant), for the treatment of platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.
  • Povofortay (povorcitinib) for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults. 
  • Sepalna (senaparib), a maintenance treatment of advanced epithelial high-grade ovarian, fallopian tube or primary peritoneal cancer. 
  • 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. 
  • Zeydovio (glepaglutide) for the treatment of short bowel syndrome. 

Biosimilars

  • 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.  

Generics

  • 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.  

Further information is available from the September 2026 CHMP meeting highlights.