EMA’s human medicines committee (CHMP) recommended seven medicines for approval at its December 2025 meeting.
The committee recommended granting a conditional marketing authorisation for Anktiva (nogapendekin alfa inbakicept), for the treatment of adults with a type of bladder cancer that affects the lining of the bladder (non-muscle invasive bladder cancer, NMIBC) and that is at high risk of growing and spreading. Bladder cancer is one of the most common cancers in the European Union (EU), affecting over 200,000 people each year, with most cases being NMIBC. See more details in the news announcement in the grid below.
The CHMP recommended granting a marketing authorisation for Aumseqa (aumolertinib), for the treatment of EGFR-mutated non-small cell lung cancer.
Exdensur (depemokimab) received a positive opinion from the CHMP for the treatment of a particular type of asthma called severe eosinophilic asthma, and for severe chronic rhinosinusitis with nasal polyps, an inflamed lining of the nose and sinuses with swellings in the nose.
The CHMP adopted a positive opinion for Myqorzo (aficamten) for the treatment of adults with obstructive hypertrophic cardiomyopathy, a disease in which the muscle in the main pumping chamber of the heart becomes thickened or enlarged, which can block the flow of blood from the heart to the rest of the body.
The committee recommended granting a marketing authorisation for Mnexspike (COVID-19 mRNA vaccine), for the prevention of COVID-19 in people from 12 years of age.
The committee adopted positive opinions for two biosimilar medicines:
The committee recommended not granting a marketing authorisation for Blarcamesine Anavex (blarcamesine), a medicine intended for the treatment of Alzheimer’s disease. The CHMP concluded that the main study failed to demonstrate the effectiveness and safety of this medicine in patients with early Alzheimer's disease who do not have mutations in the SIGMAR1 gene.
For more information on this negative opinion, see the question-and-answer document in the grid below.
The committee recommended a change to extend the use of Mounjaro (tirzepatide) for the treatment of type 2 diabetes, that is not satisfactorily controlled, to adolescents and children from 10 years of age, together with diet and physical activity. In adults, Mounjaro is also used to treat type 2 diabetes and to help individuals with obesity (BMI of 30 kg/m2 or more) or who are overweight (BMI between 27 and 30 kg/m2) and who have weight-related health problems lose weight and keep their weight under control.
The committee recommended another 11 extensions of indication for medicines that are already authorised in the EU: Arexvy, Aspaveli, Dovprela, Elucirem, Eylea, Nucala, Recarbrio, Simponi, Uplizna, Vueway and Winrevair.
An application for an initial marketing authorisation was withdrawn. Jelrix (autologous cartilage-derived articular chondrocytes, in-vitro expanded) was intended for the treatment of osteoporosis.
A question-and-answer document on the withdrawal of this medicine is available in the grid below.
The committee finalised its review of the use of Melatomed following a disagreement among EU Member States regarding its authorisation. The Agency concluded that the benefits of Melatomed outweigh its risks, and that the marketing authorisation can be granted in Germany and in the other Member States of the EU where the company has applied for a marketing authorisation (Austria, Denmark and Sweden).
For more information, see the question-and-answer document in the grid below.
The CHMP recommended changes to the existing contraindications of Vfend.
The agenda of the December 2025 CHMP meeting is published on EMA's website. Minutes of the meeting will be published in the coming weeks.
Key figures from the December 2025 CHMP meeting are represented in the graphic below.
December 2025 statistics - monthly and cumulative figures for CHMP opinions and withdrawn applications:
7 positive opinions on new medicines: 5 new non-orphan medicine, 0 orphan medicine, 2 biosimilars, and 0 generic, hybrid or informed consent medicine. Total in 2025: 104
1 negative opinions on new medicines. Total in 2025: 7
12 positive opinions on extensions of therapeutic indication. Total in 2025: 89
1 withdrawn applications for new medicines. Total in 2025: 22
nogapendekin alfa inbakicept
Serum Life Science Europe GmbH
Treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumours.
aumolertinib
SFL Pharmaceuticals Deutschland GmbH
Treatment of non-small cell lung cancer.
depemokimab
Glaxosmithkline Trading Services Limited
For severe eosinophilic asthma and for severe chronic rhinosinusitis with nasal polyps (CRSwNP).
aficamten
Cytokinetics (Ireland) Limited
Treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM) in adult patients.
COVID-19 mRNA vaccine
Moderna Biotech Spain S.L.
Active immunisation to prevent COVID 19 caused by SARS-CoV-2 in individuals 12 years of age and older.
golimumab
STADA Arzneimittel AG
Treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis and ulcerative colitis.
ranibizumab
Lupin Europe GmbH
Treatment of neovascular (wet) age-related macular degeneration (AMD), visual impairment and other retinopathies.
respiratory syncytial virus (RSV) vaccine (recombinant, adjuvanted)
GlaxoSmithKline Biologicals
pegcetacoplan
Swedish Orphan Biovitrum AB
pretomanid
Mylan IRE Healthcare Limited
gadopiclenol
Guerbet
aflibercept
Bayer AG
tirzepatide
Eli Lilly Nederland B.V
mepolizumab
Glaxosmithkline Trading Services Limited
imipenem / cilastatin / relebactam
Merck Sharp & Dohme B.V.
golimumab
Janssen Cilag International
inebilizumab
Amgen Europe B.V
gadopiclenol
Bracco Imaging S.p.A
sotatercept
Merck Sharp & Dohme B.V
autologous cartilage-derived articular chondrocytes, in-vitro expanded
TETEC Tissue Engineering Technologies AG
tasimelteon
This medicine was designated an orphan medicine.
voriconazole
Pfizer Europe MA EEIG