Meeting Highlights from the Committee for Medicinal Products for Human Use (CHMP): December 2025
The European Medicines Agency (EMA) unveiled its Committee for Medicinal Products for Human Use (CHMP) meeting outcomes from December 2025, shedding light on several significant decisions regarding medicinal products.
New Medicines Approved:
- Anktiva (Nogapendekin Alfa Inbakicept): Recommended for approval to treat adults with non-muscle invasive bladder cancer (NMIBC) at high risk of progression and spread. This condition affects over 200,000 EU residents annually, making it a prevalent concern.
- Aumseqa (Aumolertinib): A potential treatment for EGFR-mutated non-small cell lung cancer, a significant health issue in the EU.
- Exdensur (Depemokimab): Received positive feedback for treating severe eosinophilic asthma and severe chronic rhinosinusitis with nasal polyps.
- Myqorzo (Aficamten): CHMP endorsed its use in adults with obstructive hypertrophic cardiomyopathy, a heart condition that can severely impact blood flow.
- Mnexspike (COVID-19 mRNA Vaccine): Recommended for preventing COVID-19 in individuals aged 12 and above.
Biosimilar Medicines:
- Gotenfia (Golimumab): CHMP approved it for treating rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis, and ulcerative colitis.
- Ranluspec (Ranibizumab): CHMP endorsed its use for neovascular age-related macular degeneration, visual impairment, and other retinopathies.
Negative Recommendation:
- Blarcamesine Anavex (Blarcamesine): CHMP advised against granting marketing authorization for this Alzheimer's disease treatment due to insufficient evidence of its effectiveness and safety in patients without SIGMAR1 gene mutations.
Indication Extensions:
- Mounjaro (Tirzepatide): CHMP recommended extending its use for type 2 diabetes management in adolescents and children aged 10 and above, alongside dietary and physical activity adjustments.
- 11 other medicines received indication extensions for conditions like type 2 diabetes, osteoporosis, and more.
Withdrawal of Application:
- Jelrix (Autologous Cartilage-Derived Articular Chondrocytes): The application for this osteoporosis treatment was withdrawn.
Conclusion of Referral:
- Melatomed: After a review, the Agency concluded that Melatomed's benefits outweigh its risks, allowing for its authorization in Germany and other EU member states where the company applied.
Other Updates:
- Vfend: CHMP recommended changes to its existing contraindications.
Meeting Details:
- The December 2025 agenda is available on EMA's website. Meeting minutes will be published in the coming weeks.
