Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 February 2026

27 February 2026

12 new medicines recommended for approval; another six medicines recommended for extension of their therapeutic indications News Human COVID-19 Medicines Medicines for use outside the EU Vaccines

12 new medicines recommended for approval

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:

• Bysumlog (insulin lispro) and Dazparda (insulin aspart), for the treatment of diabetes.
• Fubelv (etanercept), for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis, plaque psoriasis, and paediatric plaque psoriasis.
• Poherdy (pertuzumab), for the treatment of breast cancer.
• Tuyory (tocilizumab), for the treatment of rheumatoid arthritis, COVID-19, systemic juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis, CAR-T cell-induced severe or life-threatening cytokine release syndrome, and giant cell arteritis.
• Zandoriah (teriparatide), for the treatment of osteoporosis.

Positive opinion for a medicine intended for use outside EU

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.

Negative opinion for two medicines

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.

Recommendations on extensions of therapeutic indication for six medicines

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.

Withdrawal of applications

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.

Agenda and minutes

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.

CHMP statistics

Key figures from the February 2026 CHMP meeting are represented in the graphic below.

CHMP statistics: Text version

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

Positive recommendations on new medicines

mCombriax

Common name Influenza and COVID 19, mRNA vaccine

Marketing authorisation applicant Moderna Biotech Spain S.L.

Therapeutic indication Immunisation for the prevention of influenza disease and COVID 19 caused by SARS-CoV-2

More information mCombriax: pending EC decision

News First combined COVID-19 and influenza vaccine for people 50 years and older

Ojemda

INN tovorafenib

Marketing authorisation applicant Ipsen Pharma

Therapeutic indication Treatment of paediatric low-grade glioma (LGG).

Orphan designation This medicine was designated an orphan medicine.

More information Ojemda : pending EC decision

News announcement New medicine to treat paediatric low-grade glioma

Onerji

INN levodopa / carbidopa

Marketing authorisation applicant Tanabe Pharma GmbH

Therapeutic indication Treatment of motor fluctuations in patients with Parkinson’s disease.

More information Onerji : pending EC decision

Palsonify

INN paltusotine

Marketing authorisation applicant Crinetics Pharmaceuticals Europe GmbH

Therapeutic indication Medical treatment of adult patients with acromegaly.

More information Palsonify : pending EC decision

Orphan designation This medicine was designated an orphan medicine.

Rhapsido

INN remibrutinib

Marketing authorisation applicant Novartis Europharm Limited

Therapeutic indication Treatment of chronic spontaneous urticaria (CSU) in adult patients with inadequate response to H1 antihistamine treatment.

More information Rhapsido : pending EC decision

Xolremdi

INN mavorixafor

Marketing authorisation applicant X4 Pharmaceuticals (Austria) GmbH

Therapeutic indication Treatment of WHIM syndrome.

More information Xolremdi : pending EC decision

Orphan designation This medicine was designated an orphan medicine.

Positive recommendations on new biosimilar medicines

Bysumlog

INN insulin lispro

Marketing authorisation holder Gan & Lee Pharmaceuticals Europe GmbH

Therapeutic indication Treatment of diabetes mellitus.

More information Bysumlog : pending EC decision

Dazparda

INN insulin aspart

Marketing authorisation applicant Gan & Lee Pharmaceuticals Europe GmbH

Therapeutic indication Treatment of diabetes mellitus from 1 year of age.

More information Dazparda : pending EC decision

Fubelv

INN etanercept

Marketing authorisation holder Biosimilar Collaborations Ireland Limited

Therapeutic indication Treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis (ankylosing spondylitis, non-radiographic axial spondyloarthritis), plaque psoriasis, paediatric plaque psoriasis.

More information Fubelv : pending EC decision

Poherdy

INN pertuzumab

Marketing authorisation holder Organon N.V.

Therapeutic indication Treatment of breast cancer in adults.

More information Poherdy : pending EC decision

Tuyory

INN tocilizumab

Marketing authorisation holder Chemical Works of Gedeon Richter Plc. (Gedeon Richter Plc.)

Therapeutic indication 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).

More information Tuyory : pending EC decision

Zandoriah

INN teriparatide

Marketing authorisation holder Cinnagen Co Unipessoal Lda.

Therapeutic indication Treatment of osteoporosis.

More information Zandoriah : pending EC decision

Positive opinions for medicines intended for use outside EU

Acoziborole Winthrop

International non-proprietary name (INN) acoziborole

Marketing authorisation applicant Sanofi Winthrop Industrie

Therapeutic indication Treatment of first and second-stage human African Trypanosomiases due to Trypanosoma brucei gambiense.

More information Acoziborole Winthrop : pending EC decision

News announcement New single-dose oral treatment for human African trypanosomiasis (sleeping sickness)

Negative recommendation on new medicines

Daybu

INN trofinetide

Marketing authorisation holder Acadia Pharmaceuticals (Netherlands) B.V.

Orphan designation This medicine was designated an orphan medicine.

More information Daybu : pending EC decision

Iloperidone Vanda Pharmaceuticals

INN iloperidone

Marketing authorisation holder Vanda Pharmaceuticals Netherlands B.V.

More information Iloperidone Vanda Pharmaceuticals : pending EC decision

Positive recommendations on extensions of therapeutic indications

Dupixent

INN dupilumab

Marketing authorisation holder Sanofi Winthrop Industrie

More information Dupixent : pending EC decision

Jorveza

INN budesonide

Market authorisation holder Dr. Falk Pharma GmbH

More information Jorveza : pending EC decision

Keytruda

INN pembrolizumab

Market authorisation holder Merck Sharp & Dohme B.V.

More information Keytruda : pending EC decision

Olumiant

INN baricitinib

Market authorisation holder Eli Lilly Nederland B.V.

More information Olumiant : pending EC decision

Scemblix

INN asciminib

Market authorisation holder Novartis Europharm Limited

More information Scemblix : pending EC decision

Stelara

INN ustekinumab

Market authorisation holder Janssen-Cilag International NV

More information Stelara : pending EC decision

Withdrawals of initial marketing authorisation application

Zumrad

INN sasanlimab

Marketing authorisation applicant Pfizer Europe MA EEIG

More information Zumrad : pending EC decision

Please note that not all documents associated with this page are published at the same time. This page is updated with new documents as soon as they become available. Therefore, users are asked to check the page regularly.

Related content

• Committee for Medicinal Products for Human Use (CHMP): 23-26 February 2026
• Committee for Medicinal Products for Human Use (CHMP)

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