CHMP recommends six new medicines for approval

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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 June 2026

26 June 2026

Six new medicines recommended for approval; another 11 medicines recommended for extension of their therapeutic indications

NewsHumanMedicines

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.

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.

CHMP statistics

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

© European Medicines Agency

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

• 3 negative opinions on new medicines. Total in 2026: 6

• 12 positive opinions on extensions of therapeutic indication. Total in 2026: 71

• 0 withdrawn applications for new medicines. Total in 2026: 5

Positive recommendations on new medicines

Aujemflu

Common name Influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated

Marketing authorisation applicant Seqirus Netherlands BV

Therapeutic indication Prophylaxis of influenza

More information Aujemflu : pending EC decision

Hopledo

INN levodopa / carbidopa

Marketing authorisation applicant Zambon S.p.A.

Therapeutic indication Treatment of adult patients with Parkinson’s disease

More information Hopledo : pending EC decision

Onswik

INN insulin efsitora alfa

Marketing authorisation applicant Eli Lilly Nederland B.V.

Therapeutic indication Treatment of type 2 diabetes mellitus

More information Onswik : pending EC decision

Positive recommendations on new biosimilar medicines

Denosumab Ascend

INN denosumab

Marketing authorisation applicant Ascend GmbH

Therapeutic indication Prevention of skeletal related events and treatment of giant cell tumour of bone

More information Denosumab Ascend : pending EC decision

Nylaspeg

INN pegfilgrastim

Marketing authorisation applicant Qilu Pharma Spain S.L.

Therapeutic indication Reduction of neutropoenia in adults

More information Nylaspeg : pending EC decision

Positive recommendation on re-examination of new medicine

Daybu

INN trofinetide

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

Therapeutic indication Daybu is indicated for the treatment of neurobehavioural symptoms of Rett syndrome in adults and paediatric patients aged 5 years and older

More information Daybu : pending EC decision

Orphan medicine This medicine was designated as an orphan medicine.

Negative recommendations on new medicines

Tacquell

INN autologous melanoma-derived tumour infiltrating lymphocytes, ex vivo-expanded

Marketing authorisation applicant Netherlands Cancer Institute

Therapeutic indication Treatment of melanoma

More information Tacquell : pending EC decision

Yartemlea

INN narsoplimab

Marketing authorisation applicant Omeros Ireland Limited

Therapeutic indication Treatment of patients with haemopoietic stem cell transplant-associated thrombotic microangiopathy

More information Yartemlea : pending EC decision

Orphan designation This medicine was designated an orphan medicine.

Xervyteg

INN allogeneic faecal microbiota, pooled

Marketing authorisation applicant MaaT PHARMA

Therapeutic indication Treatment of adult patients with acute-graft-versus-host disease

More information Xervyteg : pending EC decision

Positive recommendations on extensions of therapeutic indications

Datroway

INN datopotamab deruxtecan

Marketing authorisation holder Daiichi Sankyo Europe GmbH

More information Datroway : pending EC decision

Imvanex

Common name smallpox and monkeypox vaccine (live modified vaccinia virus Ankara)

Marketing authorisation holder Bavarian Nordic A/S

More information Imvanex : pending EC decision

Ixchiq

Common name Chikungunya vaccine (live)

Marketing authorisation holder Valneva Austria GmbH

More information Ixchiq : pending EC decision

Jaypirca

INN pirtobrutinib

Marketing authorisation holder Eli Lilly Nederland B.V.

More information Jaypirca : pending EC decision

Leqvio

INN inclisiran

Marketing authorisation holder Novartis Europharm Limited

More information Leqvio : pending EC decision

MenQuadfi

Common name Meningococcal Group A, C, W and Y conjugate vaccine

Marketing authorisation holder Sanofi Winthrop Industrie

More information MenQuadfi : pending EC decision

Opzelura

Common name ruxolitinib

Marketing authorisation holder Incyte Biosciences Distribution B.V.

More information Opzelura : pending EC decision

Rezolsta

INN darunavir / cobicistat

Marketing authorisation holder Janssen Cilag International

More information Rezolsta : pending EC decision

Rinvoq

INN upadacitinib

Marketing authorisation holder AbbVie Deutschland GmbH & Co. KG

More information Rinvoq : pending EC decision (VR-0000312506) Rinvoq : pending EC decision (VR-0000325958)

Stelara

INN ustekinumab

Marketing authorisation holder Janssen Cilag International

More information Stelara : pending EC decision

Symtuza

INN darunavir / cobicistat / emtricitabine / tenofovir alafenamide

Marketing authorisation holder Janssen Cilag International

More information Symtuza : pending EC decision

Tecvayli

INN teclistamab

Marketing authorisation holder Janssen-Cilag International N.V.

More information Tecvayli : pending EC decision

Start of referral procedure

Rifadin oral suspension and syrup and associated names

INN rifampicin

More information Rifadin oral suspension and syrup and associated names : referral

Conclusion of referral procedure

Tavneos

INN avacopan

More information Tavneos : referral

News EMA recommends revoking marketing authorisation for Tavneos

Other updates

Outcome of assessment on use of Mounjaro to reduce the risk of serious events affecting the heart and blood circulation

Reference Number: EMA/140483/2026

English (EN) (127.93 KB - PDF)

First published: 26/06/2026

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Start of Union reviews adopted during the CHMP meeting of 22-25 June 2026

English (EN) (104.89 KB - PDF)

First published: 26/06/2026

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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

• 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

• Xervyteg

• Orladeyo

• Aujemflu

• Denosumab Ascend

• Hopledo

• Nylaspeg

• Onswik

• Daybu

• Tacquell

• Yartemlea

• Datroway

• Imvanex

• Ixchiq

• Jaypirca

• Leqvio

• MenQuadfi

• Opzelura

• Rezolsta

• Rinvoq

• Stelara

• Symtuza

• Tecvayli

• Ixchiq

• Vyndaqel

• Dupixent

• BiResp Spiromax

• Tavneos

• Fluenz

• Mounjaro