RegulatoryOfficial

CHMP backs seven new medicines and 11 indication extensions at November meeting

🇪🇺 EMA · Fri 13 Nov 2026

EMA's human medicines committee recommended two lung cancer treatments, a hypertension drug, two insulin aspart biosimilars and two generics, and confirmed two refusals after re-examination.

The Committee for Medicinal Products for Human Use (CHMP) recommended seven medicines for EU marketing authorisation at its 9-12 November 2026 meeting, EMA announced on 13 November. Aumseqa (aumolertinib) is for non-small cell lung cancer, and Baxfendy (baxdrostat) is for insufficiently controlled hypertension. Zybrivo (sintilimab) is for non-squamous non-small cell lung cancer in adults.

The committee also adopted positive opinions on two insulin aspart biosimilars, Garzulys and Donrafylix, for diabetes mellitus in adults, adolescents and children aged one year and above. Two generics were backed: Fondaparinux sodium Evumed, for the prevention and treatment of venous thromboembolic events and other cardiovascular indications, and Ruxolitinib Krka. The latter covers myelofibrosis and polycythaemia vera in adults, and graft-versus-host disease in adults and children.

Eleven authorised medicines received recommendations for extended indications. Gazyvaro (obinutuzumab) was recommended for adults with moderate-to-severe active systemic lupus erythematosus not adequately controlled by standard treatment. EMA says it reduces disease activity while allowing patients to cut their corticosteroid use. Isturisa (osilodrostat) was recommended for endogenous Cushing's syndrome in adolescents and children aged six and older. Nine others also received positive opinions: Bexsero, Cosentyx, Dovato, Enflonsia, Steglatro, Sunlenca, Talzenna, Tivicay and Welireg.

For use outside the EU, the CHMP recommended a new 100 mg strength of the Dapivirine Vaginal Ring, which reduces the risk of HIV-1 infection in women aged 16 and over. The new strength allows the ring to be replaced every three months instead of monthly. It was assessed under the EU-Medicines for all (EU-M4All) procedure, with experts from the World Health Organization and regulators from Kenya, South Africa and Zambia taking part.

After re-examination, the committee confirmed its refusal of marketing authorisation for KemSu (sufentanil/ketamine), intended for acute pain in children and adolescents, and Meplyffa (arimoclomol citrate), intended for Niemann-Pick disease type C. CHMP opinions are sent to the European Commission, which takes the legally binding authorisation decision.

What it means for your team

  • Teams handling the seven recommended products should expect European Commission decisions to follow, and should prepare for the risk management, labelling and pharmacovigilance obligations that come with them.
  • Marketing authorisation holders of the 11 products with extended indications will need to update product information and risk management materials once the Commission's decisions are adopted.
  • The insulin aspart biosimilars and the fondaparinux and ruxolitinib generics add competition in their respective classes, which market-access teams may want to monitor.
  • The confirmed refusals for KemSu and Meplyffa end these EU applications at CHMP level after re-examination.

Official source: EMA ↗

Article written by VigiEye from the official source (EMA). AI-assisted; check the source before acting.

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