EMA Approves Seven New Medicines Including COVID-19 Vaccine and Cancer Treatments
核心洞察
The European Medicines Agency (搜索)'s CHMP (搜索) recommended approval for seven new medicines in December 2025, including Moderna's Mnexspike (搜索) COVID-19 (搜索) mRNA vaccine for people aged 12 and older.
Anktiva received conditional marketing authorization for high-risk non-muscle invasive bladder cancer (搜索), addressing a significant unmet need in a cancer affecting over 200,000 Europeans annually.
The committee also approved treatments for lung cancer, severe asthma, heart disease, and extended indications for 12 existing medicines including Mounjaro for pediatric diabetes treatment.
The European Medicines Agency (搜索)'s Committee for Medicinal Products for Human Use (CHMP (搜索)) recommended seven new medicines for approval at its December 2025 meeting, marking a significant milestone in expanding treatment options across multiple therapeutic areas including oncology, respiratory diseases, and infectious diseases.
COVID-19 Vaccine Authorization
The committee recommended granting marketing authorization for Mnexspike (搜索) (COVID-19 (搜索) mRNA vaccine) for the prevention of COVID-19 in people from 12 years of age. This approval represents Moderna's continued contribution to pandemic preparedness and vaccine accessibility for adolescents and adults.
Breakthrough Cancer Treatments
The CHMP (搜索) granted conditional marketing authorization for Anktiva (nogapendekin alfa inbakicept) for treating adults with high-risk non-muscle invasive bladder cancer (搜索) (NMIBC) that affects the bladder lining. Bladder cancer represents one of the most common cancers in the European Union, affecting over 200,000 people annually, with most cases being NMIBC.
Additionally, the committee recommended marketing authorization for Aumseqa (搜索) (aumolertinib (搜索)) for treating EGFR-mutated non-small cell lung cancer (搜索), providing a new targeted therapy option for patients with this specific genetic mutation.
Respiratory and Cardiac Disease Treatments
Exdensur (搜索) (depemokimab) received positive opinion for treating severe eosinophilic asthma (搜索) and severe chronic rhinosinusitis with nasal polyps, an inflammatory condition affecting the nose and sinuses. This approval addresses significant unmet needs in respiratory medicine for patients with these challenging conditions.
The CHMP (搜索) adopted a positive opinion for Myqorzo (搜索) (aficamten) for treating adults with obstructive hypertrophic cardiomyopathy (搜索), a disease where the heart's main pumping chamber muscle becomes thickened or enlarged, potentially blocking blood flow from the heart to the body.
Biosimilar Approvals
The committee approved two biosimilar medicines: Gotenfia (golimumab) for treating rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis and ulcerative colitis, and Ranluspec (ranibizumab) for treating neovascular age-related macular degeneration, visual impairment and other retinopathies.
Pediatric Diabetes Treatment Expansion
Among the 12 medicines receiving extended therapeutic indications, the committee recommended expanding Mounjaro (tirzepatide) use for treating type 2 diabetes (搜索) in adolescents and children from 10 years of age, combined with diet and physical activity. In adults, Mounjaro treats both type 2 diabetes and helps individuals with obesity or those who are overweight with weight-related health problems lose and maintain weight control.
Alzheimer's Treatment Rejection
The committee recommended against granting marketing authorization for Blarcamesine Anavex (搜索) (blarcamesine) for Alzheimer's disease (搜索) treatment. The CHMP (搜索) concluded that the main study failed to demonstrate effectiveness and safety in patients with early Alzheimer's disease who do not have mutations in the SIGMAR1 (搜索) gene.
Additional Regulatory Actions
The committee recommended 11 additional extensions of indication for already-authorized medicines: Arexvy, Aspaveli, Dovprela, Elucirem, Eylea, Nucala, Recarbrio, Simponi, Uplizna, Vueway and Winrevair.
One application was withdrawn: Jelrix (autologous cartilage-derived articular chondrocytes, in-vitro expanded) intended for osteoporosis treatment.
The committee also concluded its review of Melatomed following disagreement among EU Member States, determining that benefits outweigh risks and marketing authorization can be granted in Germany, Austria, Denmark and Sweden where applications were submitted.