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EMA’s human medicines committee (CHMP) recommended six medicines for approval at its June 2026 meeting.
The committee recommended granting a marketing authorisation for Aujemflu (influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated), a vaccine to protect people aged 50 years and older against influenza.
The CHMP recommended granting a marketing authorisation for Hopledo (levodopa / carbidopa) for the treatment of adult patients with Parkinson's disease and moderate-to-severe motor fluctuations (changes in the ability to move) who have not been sufficiently stabilised with oral levodopa/dopa decarboxylase inhibitor-based treatment regimens.
Onswik (insulin efsitora alfa) received a positive opinion from the CHMP for the treatment of type 2 diabetes mellitus in adults.
The committee adopted positive opinions for two biosimilar medicines:
Following a re-examination, the committee recommended granting a marketing authorisation for Daybu (trofinetide), a medicine intended for the treatment of neurobehavioural symptoms of Rett syndrome in adults and paediatric patients aged five years and older. Neurobehavioural symptoms include repetitive hand movements, restlessness, general mood problems, anxiety, sleep and communication problems. The CHMP had initially refused the application for Daybu in the treatment of Rett syndrome. After re-examination, the committee recommended that marketing authorisation could be granted, but for a restricted indication.
For more information on this outcome of re-examination, see the question-and-answer document in the grid below.
The committee adopted negative opinions for three medicines:
For more information on these negative opinions, see the question-and-answer documents in the grid below.
The CHMP adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Imvanex, a vaccine used to protect individuals 12 years of age and older against smallpox, mpox and disease caused by vaccinia virus, another virus belonging to the Poxvirus family. The committee recommended lowering the age of administration to individuals two years of age and older.
The committee recommended extensions of indication for another eleven medicines that are already authorised in the European Union (EU): Datroway, Jaypirca, Leqvio, Menquadfi, Opzelura, Orladeyo, Rezolsta, Rinvoq, Stelara, Symtuza and Tecvayli.
Two applications to extend the use of DuoResp Spiromax and BiResp Spiromax (budenoside, formoterol) as a reliever-only treatment for mild asthma were withdrawn.
Question-and-answer documents on the withdrawal of these two applications are available in the grid below.
The committee started a review of Rifadin 20 mg/ml oral suspension and syrup, a medicine containing the antibiotic rifampicin which is used to treat tuberculosis and other serious infections. The review follows concerns regarding the levels of one of the medicines’ ingredients (excipients), diethanolamine (DEA). DEA has been classified as a possible carcinogen based on studies involving rodents who were exposed over a long period of time to very high doses. The review has been initiated at the request of the Dutch medicine agency under Article 31 of Directive 2001/83/EC.
For more information, see the start of referral communication in the grid below.
The CHMP finalised its review of Tavneos (avacopan) and has recommended that the medicine’s marketing authorisation in the EU be revoked because its benefits are no longer proven to outweigh its risks. Tavneos is used to treat adults with severe, active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA), two rare inflammatory conditions of the blood vessels. The review of Tavneos was initiated to assess new information that raised questions regarding data integrity of the main study supporting the medicine’s marketing authorisation in the EU.
For more information, see the public health communication in the grid below.
The committee has recommended to allow the administration of Fluenz (Influenza vaccine (live, nasal)) by non-healthcare professionals under the supervision of a healthcare professional. Fluenz is a vaccine available as a nasal spray used to help protect children and adolescents from two years to less than 18 years old against seasonal influenza (flu).
The CHMP recommended a change to the terms of the marketing authorisation for the medicinal product Ixchiq (chikungunya vaccine (live)) to limit the use to people aged 12 years and older who are at high risk of acquiring chikungunya infection.
The CHMP has finalised the assessment of an application to extend the use of Mounjaro (tirzepatide) to reduce the risk of serious cardiovascular events, problems affecting the heart and blood circulation, in adults with type 2 diabetes who already have cardiovascular disease. Although the committee did not recommend that a new indication should be granted, it agreed to include relevant data submitted with the application in the medicine’s product information. This ensures healthcare professionals have access to up-to-date data on the effects of Mounjaro in patients with type 2 diabetes who have cardiovascular disease. For more information, see the question-and-answer document in the grid below.
The agenda of the June 2026 CHMP meeting is published on EMA's website. Minutes of the meeting will be published in the coming weeks.
Key figures from the June 2026 CHMP meeting are represented in the graphic below.
June 2026 statistics - monthly and cumulative figures for CHMP opinions and withdrawn applications:
6 positive opinions on new medicines: 3 new non-orphan medicines, 1 orphan medicine, and 2 biosimilar medicines. Total in 2026: 42
3 negative opinions on new medicines. Total in 2026: 6
13 positive opinions on extensions of therapeutic indication. Total in 2026: 72
0 withdrawn applications for new medicines. Total in 2026: 5
Influenza vaccine (surface antigen, inactivated, adjuvanted, prepared in cell culture)
Seqirus Netherlands BV
Prophylaxis of influenza
levodopa / carbidopa
Zambon S.p.A.
Treatment of adult patients with Parkinson’s disease
insulin efsitora alfa
Eli Lilly Nederland B.V.
Treatment of type 2 diabetes mellitus
denosumab
Ascend GmbH
Prevention of skeletal related events and treatment of giant cell tumour of bone
pegfilgrastim
Qilu Pharma Spain S.L.
Reduction of neutropoenia in adults
trofinetide
Acadia Pharmaceuticals (Netherlands) B.V.
Daybu is indicated for the treatment of neurobehavioural symptoms of Rett syndrome in adults and paediatric patients aged 5 years and older
This medicine was designated as an orphan medicine.
autologous melanoma-derived tumour infiltrating lymphocytes, ex vivo-expanded
Netherlands Cancer Institute
Treatment of melanoma
narsoplimab
Omeros Ireland Limited
Treatment of patients with haemopoietic stem cell transplant-associated thrombotic microangiopathy
This medicine was designated an orphan medicine.
allogeneic faecal microbiota, pooled
MaaT PHARMA
Treatment of adult patients with acute-graft-versus-host disease
datopotamab deruxtecan
Daiichi Sankyo Europe GmbH
smallpox and monkeypox vaccine (live modified vaccinia virus Ankara)
Bavarian Nordic A/S
Chikungunya vaccine (live)
Valneva Austria GmbH
pirtobrutinib
Eli Lilly Nederland B.V.
inclisiran
Novartis Europharm Limited
Meningococcal Group A, C, W and Y conjugate vaccine
Sanofi Winthrop Industrie
ruxolitinib
Incyte Biosciences Distribution B.V.
darunavir / cobicistat
Janssen Cilag International
upadacitinib
AbbVie Deutschland GmbH & Co. KG
ustekinumab
Janssen Cilag International
darunavir / cobicistat / emtricitabine / tenofovir alafenamide
Janssen Cilag International
teclistamab
Janssen-Cilag International N.V.
rifampicin
avacopan
budesonide / formoterol
budesonide / formoterol