Key Outcomes from CHMP Meeting, 8-11 December 2025
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) held a pivotal meeting from December 8-11, 2025. During this session, the committee recommended seven new medicines for approval and provided updates on several existing treatments.
Key Recommendations from the CHMP Meeting
- Anktiva (nogapendekin alfa inbakicept): Proposed for conditional marketing authorization to treat high-risk non-muscle invasive bladder cancer (NMIBC).
This type of bladder cancer is prevalent in the EU, affecting over 200,000 individuals annually. Most cases are classified as NMIBC.
- Aumseqa (aumolertinib): Recommended for patients with EGFR-mutated non-small cell lung cancer, a common lung cancer variant.
- Exdensur (depemokimab): Received a positive opinion for treating severe eosinophilic asthma and severe chronic rhinosinusitis with nasal polyps.
- Myqorzo (aficamten): Recommended for adults suffering from obstructive hypertrophic cardiomyopathy, a condition characterized by thickening of the heart muscle.
- Mnextspike: An mRNA vaccine aimed to prevent COVID-19 in individuals aged 12 years and older received a marketing authorization recommendation.
- Gotenfia (golimumab) and Ranluspec (ranibizumab): These biosimilars are recommended for various conditions, including rheumatoid arthritis and age-related macular degeneration.
Negative Opinion on Blarcamesine Anavex
The CHMP delivered a negative opinion on Blarcamesine (blarcamesine), intended for Alzheimer’s disease treatment. The committee found that the primary study did not sufficiently demonstrate its safety and efficacy for patients without specific gene mutations.
Therapeutic Indication Extensions
The committee proposed extending the therapeutic indication for Mounjaro (tirzepatide) for adolescents and children aged 10 and above. This medication is used when type 2 diabetes is not well-controlled, alongside diet and physical activity. Mounjaro is already used in adults for managing diabetes and aiding weight loss.
Additionally, CHMP recommended 11 other medicines for similar indication extensions, including Arexvy, Aspaveli, and Eylea, among others.
Withdrawals and Conclusions
A marketing authorization application for Jelrix, intended for osteoporosis, was withdrawn. Furthermore, the CHMP concluded its assessment of Melatomed, determining its benefits outweigh risks, allowing its marketing authorization in Germany and several other EU member states.
Other Updates from the December 2025 Meeting
The committee also recommended updates to contraindications for Vfend. The agenda and minutes of the meeting will be accessible on El-Balad in the upcoming weeks, providing further insights into the discussions.
