Green light for six new medicines in the EU

The European Medicines Agency (EMA) has given its approval for six new medicines, with another nine products receiving extensions for their therapeutic indications. The decisions came as the Agency’s key Committee on Human Medicines (CHMP) met for the first time in 2026.

Newly-approved products

• Fylrevy (estetrol), a hormone replacement therapy for oestrogen deficiency symptoms in postmenopausal women who have had a hysterectomy. This medicine is indicated to alleviate symptoms such as a hot face, neck and chest, also known as ‘hot flushes’.
• Ilumira (lutetium (177Lu) chloride), a radiopharmaceutical precursor, for the radiolabelling of carrier medicines that have been specifically developed and authorised for radiolabelling with lutetium chloride.
• Kayshild (semaglutide), a GLP1 receptor agonist for the treatment of non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with liver fibrosis, a serious disease where fat deposits accumulate in the liver causing inflammation.
• Kygevvi (doxecitine / doxribtimine), the first treatment for thymidine kinase 2 deficiency, a rare, life-threatening genetic disease that affects fewer than one in a million people and for which there was no authorised treatment.
• Supemtek (trivalent influenza vaccine (recombinant, prepared in cell culture)), a vaccine for the prevention of influenza in adults and children from nine years of age.
• Rezurock (belumosudil), a medicine intended for the treatment of chronic graft-versus-host disease, a condition in which donor cells of a bone marrow or stem cell transplant attack the host body. The committee concluded that this medicine is to be used when other treatment options provide limited clinical benefit, are not suitable or have been exhausted.

The committee recommended extending the use of Zynyz (retifanlimab) for the treatment of adults with squamous cell carcinoma of the anal canal (SCAC) that cannot be removed by surgery and is metastatic or locally recurrent. The CHMP also adopted a positive opinion on Eurneffy (epinephrine) with a new strength (1 mg nasal spray, solution) indicated for children with a body weight of 15 kg to less than 30 kg. Eurneffy is the first emergency treatment against allergic reactions that is administered as a nasal spray, not as an injection.

Finally, the committee recommended another seven extensions of indication for medicines that are already authorised in the EU: Akeega, Efmody, Iclusig, Imfinzi, Kerendia, Noxafil and Opdivo.