Source: European Union 2 Published on: 2026-06-26
Six new medicines recommended for approval
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:
• Denosumab Ascend (denosumab), for the prevention of bone complications in adults with advanced cancer involving bone and for the treatment of adults and skeletally mature adolescents with giant cell tumour of bone.
• Nylaspeg (pegfilgrastim), intended to reduce the duration of neutropenia (low levels of neutrophils, a type of white blood cell), and the incidence of febrile neutropenia due to chemotherapy.
Outcome of re-examination
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.
Negative opinion for three medicines
The committee adopted negative opinions for three medicines:
• Tacquell (autologous melanoma-derived tumour infiltrating lymphocytes, ex vivo-expanded), for the treatment of advanced melanoma, a skin cancer that has spread elsewhere in the body.
• Yartemlea (narsoplimab), for the treatment of adults and children from two years of age with haematopoietic stem cell transplant (HSCT)-associated thrombotic microangiopathy. Thrombotic microangiopathy is a serious and potentially life-threatening complication following HSCT, a procedure where the patient’s bone marrow is replaced by stem cells from a donor to form new bone marrow that produces healthy cells.
• Xervyteg (allogeneic faecal microbiota, pooled), for the treatment of acute graft-versus-host disease (aGvHD), a serious, life-threatening condition, where the donor cells of a bone marrow or stem cell transplant attack the host body shortly after the transplant.
For more information on these negative opinions, see the question-and-answer documents in the grid below.
Recommendations on extensions of therapeutic indication for 11 medicines
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 ten medicines that are already authorised in the European Union (EU): Datroway, Jaypirca, Leqvio, Menquadfi, Opzelura, Rezolsta, Rinvoq, Stelara, Symtuza and Tecvayli.
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.
Conclusion of referral
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.
CHMP statistics: Text version
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
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
3 negative opinions on new medicines. Total in 2026: 6
• 12 positive opinions on extensions of therapeutic indication. Total in 2026: 71
12 positive opinions on extensions of therapeutic indication. Total in 2026: 71
• 0 withdrawn applications for new medicines. Total in 2026: 5
0 withdrawn applications for new medicines. Total in 2026: 5
Positive recommendations on new medicines
Influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated
Seqirus Netherlands BV
Prophylaxis of influenza
Aujemflu : pending EC decision
levodopa / carbidopa
Treatment of adult patients with Parkinson’s disease
insulin efsitora alfa
Eli Lilly Nederland B.V.
Treatment of type 2 diabetes mellitus
Positive recommendations on new biosimilar medicines
Prevention of skeletal related events and treatment of giant cell tumour of bone
Denosumab Ascend : pending EC decision
Qilu Pharma Spain S.L.
Reduction of neutropoenia in adults
Nylaspeg : pending EC decision
Positive recommendation on re-examination of new medicine
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.
Negative recommendations on new medicines
autologous melanoma-derived tumour infiltrating lymphocytes, ex vivo-expanded
Netherlands Cancer Institute
Treatment of melanoma
Tacquell : pending EC decision
Omeros Ireland Limited
Treatment of patients with haemopoietic stem cell transplant-associated thrombotic microangiopathy
Yartemlea : pending EC decision
This medicine was designated an orphan medicine.
allogeneic faecal microbiota, pooled
Treatment of adult patients with acute-graft-versus-host disease
Xervyteg : pending EC decision
Positive recommendations on extensions of therapeutic indications
datopotamab deruxtecan
Daiichi Sankyo Europe GmbH
Datroway : pending EC decision
smallpox and monkeypox vaccine (live modified vaccinia virus Ankara)
Chikungunya vaccine (live)
Valneva Austria GmbH
Eli Lilly Nederland B.V.
Jaypirca : pending EC decision
Novartis Europharm Limited
Meningococcal Group A, C, W and Y conjugate vaccine
Sanofi Winthrop Industrie
MenQuadfi : pending EC decision
Incyte Biosciences Distribution B.V.
Opzelura : pending EC decision
darunavir / cobicistat
Janssen Cilag International
Rezolsta : pending EC decision
AbbVie Deutschland GmbH & Co. KG
Rinvoq : pending EC decision (VR-0000312506)
Rinvoq : pending EC decision (VR-0000325958)
Janssen Cilag International
darunavir / cobicistat / emtricitabine / tenofovir alafenamide
Janssen Cilag International
Janssen-Cilag International N.V.
Tecvayli : pending EC decision
Start of referral procedure
Rifadin oral suspension and syrup and associated names
Rifadin oral suspension and syrup and associated names : referral
Conclusion of referral procedure
EMA recommends revoking marketing authorisation for Tavneos
Outcome of assessment on use of Mounjaro to reduce the risk of serious events affecting the heart and blood circulation
English (EN) (127.93 KB – PDF)
Start of Union reviews adopted during the CHMP meeting of 22-25 June 2026
English (EN) (104.89 KB – PDF)
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.
• EMA recommends revoking marketing authorisation for Tavneos
• Committee for Medicinal Products for Human Use (CHMP): 22-25 June 2026
• Committee for Medicinal Products for Human Use (CHMP)
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Related medicine information
• Rifadin oral suspension and syrup and associated names – referral