The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the approval of 12 medicines during its February 2026 meeting, including a first-of-its-kind combination vaccine for influenza and COVID-19 and a new therapy for a rare childhood brain tumor. The recommendations, announced Friday, cover a range of conditions from common seasonal illnesses to ultra-rare genetic disorders.
The CHMP recommended granting a marketing authorisation for mCombriax, developed by Moderna, as a single vaccine protecting individuals aged 50 and older against both COVID-19 and seasonal influenza. According to Moderna CEO Stéphane Bancel, the positive CHMP opinion marks “an important milestone for respiratory virus vaccination” and would be the company’s fourth marketed product in Europe if approved by the European Commission. As of February 1, 2026, Europe had reported over 281 million cases of COVID-19, and seasonal influenza affects up to 50 million people annually in the European Economic Area.
In a significant development for pediatric oncology, the committee similarly recommended conditional marketing authorisation for Ojemda (tovorafenib) for the treatment of paediatric low-grade glioma, a non-cancerous brain tumor affecting children. Current treatment options, surgery and chemotherapy, often have limited effectiveness and substantial side effects. Ojemda offers a once-weekly oral therapy for a broader patient group.
Further positive opinions were issued for Onerji (levodopa / carbidopa) for advanced Parkinson’s disease, Palsonify (paltusotine) for acromegaly, Rhapsido (remibrutinib) for chronic spontaneous urticaria, and Xolremdi (mavorixafor) for WHIM syndrome, a rare hereditary immune deficiency. Xolremdi received a positive opinion under exceptional circumstances, intended for patients aged 12 and older.
The CHMP also recommended the approval of six biosimilar medicines: Bysumlog and Dazparda (both for diabetes), Fubelv (for rheumatoid arthritis and related conditions), Poherdy (for breast cancer), Tuyory (for rheumatoid arthritis, COVID-19, and other inflammatory conditions), and Zandoriah (for osteoporosis).
Beyond medicines for the EU market, the committee issued a positive opinion for Acoziborole Winthrop (acoziborole), a single-dose oral treatment for human African trypanosomiasis (sleeping sickness) caused by Trypanosoma brucei gambiense. This recommendation was made under the EU-Medicines for all (EU-M4All) initiative, aimed at bolstering global regulatory capacity and public health.
But, not all applications received positive reviews. The CHMP recommended against granting marketing authorisation for Daybu (trofinetide) for Rett syndrome and Iloperidone Vanda Pharmaceuticals (iloperidone) for schizophrenia and bipolar disorder. Question-and-answer documents detailing the reasons for these negative opinions have been published by the EMA.
The committee also recommended extensions of therapeutic indication for six existing medicines: Dupixent, Jorveza, Keytruda, Olumiant, Scemblix and Stelara. Dupixent’s extension allows for its use in treating chronic spontaneous urticaria in children aged 2 to 11, representing the first biologic treatment for this population. Jorveza will be available in a pediatric-specific formulation for eosinophilic oesophagitis in patients aged 2 to 17.
One application for initial marketing authorisation, for Zumrad (sasanlimab) intended for the treatment of bladder cancer, was withdrawn by the applicant. The agenda and minutes from the February 2026 CHMP meeting are available on the EMA website, with the full minutes expected to be published in the coming weeks.
