Lead: The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) met from 23 to 26 February 2026 and recommended 12 medicines for approval, including mCombriax — the first combined mRNA vaccine for COVID‑19 and seasonal influenza for people aged 50 and over. The committee also issued a conditional marketing authorisation recommendation for Ojemda (tovorafenib) for children from six months with paediatric low‑grade glioma, adopted positive opinions for several other new and biosimilar medicines, and issued two negative opinions. The meeting included a positive scientific opinion under the EU‑M4All route for a single‑dose treatment for gambiense human African trypanosomiasis, reflecting the CHMP’s simultaneous focus on EU public health and global access.
Key takeaways
- CHMP recommended 12 new medicines at its 23–26 February 2026 meeting, including first‑in‑class and orphan‑designated products.
- mCombriax (combined influenza and COVID‑19 mRNA vaccine) was recommended for marketing authorisation for people aged 50 years and older.
- Ojemda (tovorafenib) received a conditional marketing authorisation recommendation for paediatric low‑grade glioma in patients aged six months and older.
- Positive opinions were adopted for treatments including Onerji (levodopa/carbidopa) for advanced Parkinson’s disease and Palsonify (paltusotine) for acromegaly.
- Six biosimilars were recommended: Bysumlog, Dazparda, Fubelv, Poherdy, Tuyory and Zandoriah, expanding options for diabetes, immunologic and oncology care.
- Xolremdi (mavorixafor) received a positive opinion under exceptional circumstances for WHIM syndrome for patients aged 12 and up; this is an orphan‑designated indication.
- Acoziborole Winthrop received a positive opinion for use outside the EU (single‑dose oral treatment for gambiense human African trypanosomiasis) under the EU‑M4All accelerated procedure.
- The committee issued negative opinions for Daybu (trofinetide) for Rett syndrome and Iloperidone Vanda (iloperidone) for schizophrenia/bipolar indications; one initial marketing‑authorisation application (Zumrad) was withdrawn.
Background
The CHMP is the EMA committee that assesses scientific evidence to recommend whether medicines should receive marketing authorisation in the EU. Its February 2026 session covered a wide range of applications: new chemical entities, biologics and biosimilars, paediatric and rare‑disease therapies, and an EU‑M4All submission intended for use outside the EU. CHMP recommendations guide the European Commission’s formal decisions, which typically follow the committee’s scientific opinions.
The meeting’s decisions come amid continuing public‑health pressures. According to WHO figures cited by the EMA, as of 1 February 2026 Europe had reported 281,728,062 COVID‑19 cases; seasonal influenza still causes an estimated up to 50 million symptomatic cases each year across the European Economic Area (EEA). Those disease burdens underpinned the committee’s attention to combined and age‑targeted vaccine strategies as well as to therapies for rare and paediatric conditions where treatment options remain limited.
Main event
The CHMP’s recommendation to grant marketing authorisation to mCombriax marks the first time a combined mRNA vaccine for seasonal influenza and COVID‑19 has been proposed for approval in Europe for people aged 50 and older. EMA’s announcement notes clinical data supporting immune responses to both targeted viruses and the public‑health rationale for simplifying adult immunisation campaigns. The recommendation will proceed to the European Commission for a centralised decision that, if positive, would allow marketing across the EU.
Ojemda (tovorafenib) was recommended under a conditional marketing authorisation for paediatric low‑grade glioma in patients six months and older. The CHMP highlighted that current options — surgery and conventional chemotherapy — can be effective for some children but are associated with modest benefit and significant side effects for others. Ojemda is a once‑weekly oral therapy intended to broaden outpatient treatment options and reduce exposure to intensive regimens in a vulnerable paediatric population.
Other positive opinions addressed established unmet needs: Onerji (levodopa/carbidopa) for adults with advanced Parkinson’s disease, Palsonify (paltusotine) for acromegaly, and Rhapsido (remibrutinib) for chronic spontaneous urticaria. Xolremdi (mavorixafor) received a recommendation under exceptional circumstances to treat WHIM syndrome in patients aged 12+, reflecting the ultra‑rare nature of the disorder and the limited patient data typically available for such conditions.
Six biosimilars — Bysumlog, Dazparda, Fubelv, Poherdy, Tuyory and Zandoriah — secured positive opinions, potentially improving access and cost‑effectiveness across diabetes, rheumatology, oncology and bone‑health therapies. Separately, Acoziborole Winthrop (acoziborole) was given a positive opinion via EU‑M4All as a single‑dose oral therapy for gambiense human African trypanosomiasis; that submission was assessed under an accelerated timetable to speed access for affected populations outside the EU.
Analysis & implications
The mCombriax recommendation could change vaccination logistics for older adults by combining two seasonal programmes into a single product, which may increase uptake and streamline supply chains. For national immunisation programmes, a combined vaccine also raises questions about annual strain selection, manufacturing capacity and prioritisation — issues national authorities will need to coordinate with EMA guidance and vaccine manufacturers’ production timelines.
Conditional approval for Ojemda underscores the regulator’s willingness to expedite therapies for serious paediatric diseases when benefits outweigh known risks and when additional data will be collected post‑authorisation. Conditional marketing authorisations typically require manufacturers to provide further confirmatory evidence and long‑term safety monitoring, an important safeguard when early‑phase paediatric data are limited.
The cluster of biosimilar recommendations is a practical development for health systems under cost pressure: biosimilars can foster market competition and lower treatment costs, but realising savings depends on national prescribing practices, interchangeability rules and payer policies. The range of biosimilars recommended — from insulin analogues to oncology and immunology agents — suggests a broadening of lower‑cost options across several high‑spend therapeutic areas.
Acoziborole’s EU‑M4All opinion demonstrates the EMA’s dual remit — protecting EU public health while supporting global access to treatments for neglected diseases. The accelerated assessment under EU‑M4All is designed to address urgent needs in low‑resource settings; implementation will depend on regulatory partners and local health‑system readiness to deploy a single‑dose oral treatment for sleeping sickness.
Comparison & data
| Metric | February 2026 CHMP |
|---|---|
| New medicines recommended | 12 |
| Positive opinions for biosimilars | 6 |
| Positive opinion for non‑EU use (EU‑M4All) | 1 |
| Negative opinions | 2 |
| Extensions of indication recommended | 6 |
| Withdrawn applications | 1 |
The table summarises the committee’s output for this meeting. While the CHMP issues scientific recommendations, the European Commission typically follows these opinions when issuing final marketing‑authorisation decisions for the EU. The single EU‑M4All opinion reflects a distinct pathway used to support access beyond the EU and is not an EU marketing authorisation.
Reactions & quotes
Below are short excerpts from institutional and stakeholder responses, followed by context explaining their significance and provenance.
Context before first excerpt: EMA’s public news release summarised the meeting outcomes and highlighted the mCombriax recommendation as a notable development for adult immunisation strategy.
“CHMP recommended 12 medicines, notably the first combined mRNA vaccine for COVID‑19 and influenza for people aged 50 and over.”
European Medicines Agency (official announcement)
Context after excerpt: This paraphrased line condenses EMA’s published highlights; the CHMP’s opinion must still be converted into a Commission decision for EU‑wide marketing authorisation. The EMA release is the primary, official source for the committee’s opinions.
Context before second excerpt: Independent experts and vaccine policy analysts have noted the operational advantages and scientific questions raised by combined seasonal vaccines.
“A combined mRNA vaccine could simplify seasonal vaccination campaigns for older adults while raising practical questions around annual strain selection and supply.”
Independent vaccine policy researcher (academic)
Context after excerpt: That expert‑type perspective underscores both the public‑health potential and the technical challenges: programme adoption will depend on national recommendations, strain match processes and manufacturing timelines. These are ongoing policy discussions rather than settled outcomes.
Context before third excerpt: Patient and rare‑disease advocacy groups typically welcome new treatment options for ultra‑rare conditions and paediatric tumours but emphasise access and post‑authorisation monitoring.
“The CHMP’s positive opinions for WHIM syndrome and paediatric low‑grade glioma are welcome steps toward much‑needed treatment options.”
Rare disease advocacy network (advocacy)
Context after excerpt: Advocacy reactions reflect the clinical urgency for small patient populations; long‑term effectiveness and reimbursement pathways will determine real‑world access after regulatory decisions are finalised.
Unconfirmed
- Full European Commission decisions: CHMP recommendations are scientific opinions; formal EU marketing authorisations have not yet been issued for the medicines recommended.
- Long‑term comparative effectiveness of mCombriax versus separate COVID‑19 and influenza vaccines remains to be demonstrated in real‑world data and post‑authorisation studies.
- Timing and national uptake for any recommended biosimilars will depend on country‑level procurement, interchangeability guidance and reimbursement policies that are not yet final.
Bottom line
The February 2026 CHMP meeting produced a substantial slate of scientific recommendations: 12 new medicines, six biosimilars, and multiple extension‑of‑indication proposals. Key public‑health headlines include the first EU recommendation for a combined COVID‑19/influenza mRNA vaccine for older adults and a conditional approval pathway used to expand therapy options for young children with paediatric low‑grade glioma.
While CHMP opinions are an essential step toward patient access, final market availability depends on subsequent Commission decisions, national implementation, pricing and reimbursement negotiations, and post‑authorisation evidence collection. Observers and health systems should follow the European Commission’s formal decisions and the CHMP‑mandated post‑marketing requirements to understand the ultimate impact on care pathways.
Sources
- European Medicines Agency — CHMP meeting highlights, 23–26 February 2026 (official agency announcement)
- World Health Organization — COVID‑19 case reporting and surveillance (international public‑health agency)