12 New Medicines Recommended for Approval
The European Medicines Agency’s human medicines committee (CHMP) has put forward recommendations for 12 new medicines as of its February 2026 meeting.
Among the recommended products is mCombriax, an mRNA vaccine aimed at those aged 50 and above, designed to combat both COVID-19 and seasonal flu. Recent figures from the World Health Organization (WHO) indicate that Europe has recorded over 281 million COVID-19 cases by February 1, 2026. Additionally, seasonal flu continues to be a major health concern, impacting up to 50 million individuals each year in the European Economic Area (EEA). Further details can be found in the announcement below.
The committee has also recommended a conditional marketing authorization for Ojemda, intended for patients from six months and older suffering from paediatric low-grade glioma— a benign type of brain tumor. While treatments like surgery and chemotherapy are standard, chemotherapy’s effectiveness can vary, and side effects are often considerable. This new oral therapy offers a once-weekly option for a wider range of young patients with this condition. More information is available in the announcement below.
Additionally, Onerji (levodopa / carbidopa) received a favorable opinion for adults with advanced Parkinson’s disease, a nervous system disorder marked by symptoms like tremors and balance issues.
Palsonify (paltusotine) gained a positive opinion for addressing acromegaly, a rare hormonal disorder that typically affects middle-aged adults through the overproduction of growth hormone by the pituitary gland.
The CHMP also issued a favorable opinion for Rhapsido (remibrutinib), which is intended for treating chronic spontaneous urticaria, a persistent itchy rash.
In exceptional circumstances, Xolremdi (mavorixafor) also received positive feedback for treating WHIM syndrome, a very rare genetic disorder that compromises the immune system, increasing susceptibility to infections. This condition can be debilitating and life-threatening due to recurrent infections. The medicine is aimed at patients aged 12 and above.
The committee has expressed positive opinions for six biosimilar medicines:
- Bysumlog (insulin lispro) and Dazparda (insulin aspart) for diabetes treatment.
- Fubelv (etanercept) for conditions such as rheumatoid arthritis and plaque psoriasis.
- Poherdy (pertuzumab) for breast cancer therapy.
- Tuyory (tocilizumab) addressing multiple arthritis types and severe reactions to CAR-T cell therapy.
- Zandoriah (teriparatide) for osteoporosis management.
Positive Opinion for Off-EU Medicine
The committee offered a positive opinion for Acoziborole Winthrop (acoziborole), a one-time oral treatment for human African trypanosomiasis, often known as sleeping sickness, caused by the Trypanosoma brucei gambiense. This medicine streamlines treatment for both early and advanced stages of this illness.
Acoziborole Winthrop was submitted through a procedure termed EU-Medicines for all (EU-M4All), which allows the Agency to assist in global regulatory efforts and enhance public health initiatives outside the EU. The application was processed rapidly to facilitate quicker access for patients.
More details are available in the announcement below.
Negative Opinions for Two Medicines
The committee decided against granting marketing authorization for Daybu (trofinetide), intended for Rett syndrome treatment—a genetic disorder associated with intellectual disabilities and skill regression among young children.
Iloperidone Vanda Pharmaceuticals (iloperidone) also received a negative opinion from the CHMP for its use in schizophrenia and bipolar disorder episodes.
For further insights regarding these negative evaluations, please check the question-and-answer documents below.
Recommendations for Extension of Therapeutic Uses
The committee recommended expanding use for Dupixent (dupilumab) to include treatment of chronic spontaneous urticaria in children aged 2 to 11 years, marking it as the first biologic treatment for children under 12 with this condition.
A positive opinion was also issued to extend Jorveza (budesonide) for treating eosinophilic oesophagitis, a rare inflammation of the esophagus, for patients aged 2 to 17. This will introduce a formulation specifically for younger patients to meet an unmet need, addressing issues arising from using adult medications off-label.
The committee further recommended extensions for four other already authorized medicines: Keytruda, Olumiant, Scemblix and Stelara.
Withdrawn Applications
An initial marketing authorization application was withdrawn for Zumrad (sasanlimab), intended for bladder cancer treatment.
A document detailing the withdrawal is accessible below.
Meeting Agenda and Minutes
The agenda for the February 2026 CHMP meeting has been published on the EMA’s website, with meeting minutes expected to follow in the coming weeks.
