EMA’s human medicines committee (CHMP) recommended 12 medicines for approval at its February 2026 meeting.
The committee recommended granting a marketing authorisation for mCombriax (influenza and COVID-19 mRNA vaccine), the first combined messenger RNA vaccine for protecting people aged 50 years and older against COVID-19 and seasonal influenza (flu). According to data released by the World Health Organization (WHO), as of 1 February 2026, there had been 281,728,062 cases of COVID-19 reported in Europe. Seasonal influenza also presents a significant burden, with up to 50 million symptomatic cases of seasonal influenza occurring every year in the European Economic Area (EEA). See more details in the news announcement in the grid below.
The CHMP recommended granting a conditional marketing authorisation for Ojemda (tovorafenib), to treat patients aged six months and older with paediatric low-grade glioma, a type of non-cancerous brain tumour. Current treatment options include surgery and chemotherapy. While chemotherapy can be effective for some patients, its benefits are often modest and it may cause substantial side effects. Ojemda is a new once-weekly oral therapy for a broader group of patients with paediatric low-grade glioma. See more details in the news announcement in the grid below.
The CHMP adopted a positive opinion for Onerji (levodopa / carbidopa), for the treatment of adults with advanced Parkinson's disease, a progressive disease of the nervous system that causes shaking, stiffness, slow movement and problems maintaining balance.
Palsonify (paltusotine) received a positive opinion from the CHMP for the treatment of acromegaly, a rare hormonal disorder that usually occurs in middle-aged adults and is caused by the pituitary gland producing excess growth hormone.
The committee adopted a positive opinion for Rhapsido (remibrutinib), for the treatment of chronic spontaneous urticaria, a long-term itchy rash.
Xolremdi (mavorixafor), received a positive opinion under exceptional circumstances from the CHMP for the treatment of WHIM syndrome, an ultra-rare hereditary condition in which the immune system (the body’s natural defences) does not work properly, making patients more susceptible to bacterial and viral infections. WHIM stands for warts (skin growths), hypogammaglobulinemia (low level of antibodies), infections and myelokathexis (a condition where immune cells are trapped in the bone marrow preventing them from fighting infections). WHIM syndrome is a long-term debilitating and life-threatening condition because of the recurrent infections and the increased risk of developing viral-associated cancer over time. This medicine is intended for patients from 12 years of age.
The committee adopted positive opinions for six biosimilar medicines:
The committee adopted a positive opinion for Acoziborole Winthrop (acoziborole), a single-dose oral treatment for human African trypanosomiasis (sleeping sickness) caused by Trypanosoma brucei gambiense. This medicine simplifies treatment of first- and second-stage gambiense human African trypanosomiasis.
Acoziborole Winthrop was submitted under a regulatory procedure known as EU-Medicines for all (EU-M4All) that enables the Agency to support global regulatory capacity building and contribute to the protection and promotion of public health beyond the EU. The application for scientific opinion was assessed under an accelerated timetable to enable faster patient access to this medicine.
See more details in the news announcement in the grid below.
The committee recommended not granting a marketing authorisation for Daybu (trofinetide), a medicine intended for the treatment of Rett syndrome, a genetic disease characterised by intellectual disability as well as by loss of speech and regression of acquired skills between 6 and 18 months of age.
Iloperidone Vanda Pharmaceuticals (iloperidone) received a negative opinion from the CHMP for the treatment of schizophrenia and acute treatment of manic or mixed episodes associated with bipolar disorder.
For more information on these negative opinions, see the question-and-answer documents in the grid below.
The committee recommended to extend the use of Dupixent (dupilumab), for the treatment of chronic spontaneous urticaria in children aged 2 to 11 years. This is the first biologic treatment for a paediatric population under 12 years of age with this condition.
The CHMP adopted a positive opinion to extend the use of Jorveza (budesonide) for the treatment of eosinophilic oesophagitis, a rare inflammatory condition of the oesophagus, in patients aged 2 to 17 years. Jorveza will be available in a paediatric-specific formulation which addresses an unmet medical need and off-label use of adult formulations. Off-label use is the use of a medicine for an unapproved indication or in an unapproved age group, dosage, or route of administration.
The committee recommended another four extensions of indication for medicines that are already authorised in the EU: Keytruda, Olumiant, Scemblix and Stelara.
An application for an initial marketing authorisation was withdrawn. Zumrad (sasanlimab) was developed for the treatment of bladder cancer.
A question-and-answer document on the withdrawal of this medicine is available in the grid below.
The agenda of the February 2026 CHMP meeting is published on EMA's website. Minutes of the meeting will be published in the coming weeks.
Key figures from the February 2026 CHMP meeting are represented in the graphic below.
February 2026 statistics - monthly and cumulative figures for CHMP opinions and withdrawn applications:
12 positive opinions on new medicines: 3 new non-orphan medicine, 3 orphan medicines, 6 biosimilars, and 0 generic, hybrid or informed consent medicine. Total in 2026: 18
2 negative opinions on new medicines. Total in 2026: 2
6 positive opinions on extensions of therapeutic indication. Total in 2026: 15
1 withdrawn applications for new medicines. Total in 2026: 1
Influenza and COVID 19, mRNA vaccine
Moderna Biotech Spain S.L.
Immunisation for the prevention of influenza disease and COVID 19 caused by SARS-CoV-2
tovorafenib
Ipsen Pharma
Treatment of paediatric low-grade glioma (LGG).
This medicine was designated an orphan medicine.
levodopa / carbidopa
Tanabe Pharma GmbH
Treatment of motor fluctuations in patients with Parkinson’s disease.
paltusotine
Crinetics Pharmaceuticals Europe GmbH
Medical treatment of adult patients with acromegaly.
This medicine was designated an orphan medicine.
remibrutinib
Novartis Europharm Limited
Treatment of chronic spontaneous urticaria (CSU) in adult patients with inadequate response to H1 antihistamine treatment.
mavorixafor
X4 Pharmaceuticals (Austria) GmbH
Treatment of WHIM syndrome.
This medicine was designated an orphan medicine.
insulin lispro
Gan & Lee Pharmaceuticals Europe GmbH
Treatment of diabetes mellitus.
insulin aspart
Gan & Lee Pharmaceuticals Europe GmbH
Treatment of diabetes mellitus from 1 year of age.
etanercept
Biosimilar Collaborations Ireland Limited
Treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis (ankylosing spondylitis, non-radiographic axial spondyloarthritis), plaque psoriasis, paediatric plaque psoriasis.
pertuzumab
Organon N.V.
Treatment of breast cancer in adults.
tocilizumab
Chemical Works of Gedeon Richter Plc. (Gedeon Richter Plc.)
Treatment of rheumatoid arthritis (RA), coronavirus disease 2019 (COVID-19), systemic juvenile idiopathic arthritis (sJIA), polyarticular juvenile idiopathic arthritis (pJIA), CAR-T cell-induced severe or life-threatening cytokine release syndrome (CRS), and giant cell arteritis (GCA).
teriparatide
Cinnagen Co Unipessoal Lda.
Treatment of osteoporosis.
acoziborole
Sanofi Winthrop Industrie
Treatment of first and second-stage human African Trypanosomiases due to Trypanosoma brucei gambiense.
trofinetide
Acadia Pharmaceuticals (Netherlands) B.V.
This medicine was designated an orphan medicine.
iloperidone
Vanda Pharmaceuticals Netherlands B.V.
dupilumab
Sanofi Winthrop Industrie
budesonide
Dr. Falk Pharma GmbH
pembrolizumab
Merck Sharp & Dohme B.V.
baricitinib
Eli Lilly Nederland B.V.
asciminib
Novartis Europharm Limited
ustekinumab
Janssen-Cilag International NV
sasanlimab
Pfizer Europe MA EEIG