Six new medicines recommended for approvalEMA’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.
Onswik (insulin efsitora alfa) received a positive opinion from the CHMP for the treatment of type 2 diabetes mellitus in adults.
After re-examination, the committee recommended that marketing authorisation could be granted, but for a restricted indication.
The committee recommended lowering the age of administration to individuals two years of age and older.
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.
(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.
(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.
(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 12 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 eleven medicines that are already authorised in the European Union (EU): Datroway, Jaypirca, Leqvio, Menquadfi, Opzelura, Orladeyo, Rezolsta, Rinvoq, Stelara, Symtuza and Tecvayli.
Withdrawal of applications
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.
Start of referral
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.
Other updates
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.
Agenda and minutes
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.
