European Medicines Agency (EMA) CHMP Meeting Highlights – 26–29 January 2026

The EMA’s Committee for Medicinal Products for Human Use (CHMP) concluded its January 2026 session with a range of key regulatory recommendations that could shape the European pharmaceutical landscape. During the meeting, the CHMP:

New Medicines Recommended for Approval

The CHMP issued positive opinions on six new medicines, including:

• Fylrevy (estetrol) – a hormone replacement therapy for alleviating menopausal symptoms.
• Ilumira (lutetium-177 chloride) – a radiopharmaceutical precursor intended for specialised radiolabelling procedures.
• Kayshild (semaglutide) – a GLP-1 receptor agonist for non-cirrhotic MASH with liver fibrosis — the first in its class for this indication.
• Kygevvi – an orphan medicine for thymidine kinase 2 deficiency, a rare neuromuscular disorder.
• Supemtek – a trivalent recombinant influenza vaccine for seasonal flu prevention.
• Rezurock (belumosudil) received a conditional marketing authorisation for chronic graft-versus-host disease following re-examination.

 Therapeutic Indication Extensions

The CHMP also recommended nine extensions of therapeutic use for existing medicines, such as:

• Zynyz (retifanlimab) for squamous cell carcinoma of the anal canal.
• Eurneffy (epinephrine) nasal spray with a new dosing option for paediatric allergic emergencies.
• And extended indications for Akeega, Efmody, Iclusig, Imfinzi, Kerendia, Noxafil, Opdivo in various therapeutic areas.

 Other Significant Updates

• CHMP initiated a referral review of Tavneos (avacopan) due to questions about the integrity of supporting clinical data.
• The committee also finalised the assessment of Mounjaro (tirzepatide) for potential clinical data inclusion in its label regarding heart failure with preserved ejection fraction in obesity.

These recommendations now proceed to the European Commission for final authorisation decisions and will inform treatment options across the EU market.

For more information: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 26-29 January 2026