During its meeting from November 10 to 13 in the year 2025, the EMA-CHMP gave out a positive opinion which proposed the granting of marketing authorisation for ten new medicines and additionally suggested therapeutic-indication extensions for four already authorised medicines to the Commissioners of the European Union. The recommendations cover a wide therapeutic area, such as hereditary angioedema and PET-imaging radionuclide therapy—shedding a light on the wide coming EU-level drug approvals wave. The final decision will be made by the European Commission.
💡 New Medicines Recommended
Here are some of the notable medicines:
| Medicine & Developer | Indication / Key Feature |
|---|---|
| Teizeild (anti-CD3 antibody, by Sanofi) | Recommended for delaying onset of stage 3 type-1 diabetes in patients (children from 8 years & adults) with stage-2 T1D — potentially first-in-class preventive therapy. European Medicines Agency (EMA)+pharmaphorum |
| Waskyra (etuvetidigene autotemcel, gene therapy) | For treatment of Wiskott-Aldrich syndrome (WAS) in patients (from 6 months of age) lacking a suitable stem-cell donor — first gene-therapy approved by CHMP for this rare immunodeficiency. European Medicines Agency (EMA) Insights |
| Dawnzera (donidalorsen, by Ionis Pharmaceuticals / partner) | Recommended for routine prevention of recurrent attacks of Hereditary Angioedema (HAE) in adolescents (≥ 12 yrs) and adults. maestrodatabase.com+ir.ionis.com |
Note: Public sources mention these three explicitly by name among the 10. Full detailed public list of all 10 drugs — including biosimilars, generics, specialized therapies — is not fully disclosed yet in a manner suitable for press-style summaries. European Medicines Agency (EMA)
🔁 Indication Extensions for Previously-Authorised Medicines
CHMP recommended indication extensions for four existing medicines. Publicly known medicines among them include:
- Koselugo
- Minjuvi
- Veyvondi
- Xerava
These extensions may include new therapeutic uses, broader patient populations or new formulations. therqa.com
📝 Context & Implications
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The inclusion of both rare-disease gene therapy (Waskyra) and autoimmune / metabolic disease (Teizeild) in the same batch shows CHMP’s expanding scope: from ultra-rare diseases to high-prevalence chronic indications.
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For the EU pharmaceutical market — and for B2B buyers / CDMOs / distributors globally — this recommendation round signals potential new supply contracts, licensing opportunities, and market launches in 2026 onwards.
⚠️ Why Not All 10 Drugs Are Named Publicly Yet
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The official public summary from CHMP does not list all 10 medicines by name — for some, the sponsor may not yet have final labelling or commercial name publicly disclosed. European Medicines Agency (EMA)+synopulse.com
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Hence, a fully detailed list may require waiting for the European Commission final authorisation and/or public EPAR documents (European Public Assessment Reports) which typically publish full product info.
Source Reference:
EMA CHMP 10-13 Nov 2025 Meeting Highlights:
https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-10-13-november-2025
