Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 26-29 January 2026

30 January 2026

Six new medicines recommended for approval; another nine medicines recommended for extension of their therapeutic indications News Human Medicines

Updated on 5 February 2026:
Updating the paragraph on Eurneffy to add the full indication.

Six new medicines recommended for approval

EMA’s human medicines committee (CHMP) recommended six medicines for approval at its January 2026 meeting.

The committee recommended granting a marketing authorisation for Fylrevy (estetrol), a hormone replacement therapy for oestrogen deficiency symptoms in postmenopausal women. During menopause, the amount of oestrogen produced by a woman’s body drops. This can cause symptoms such as a hot face, neck and chest, also known as ‘hot flushes’. This medicine is indicated to alleviate these symptoms.

Ilumira (lutetium (177 Lu) chloride), **** a radiopharmaceutical precursor, received a positive opinion from the CHMP. Ilumira must be used only for the radiolabelling of carrier medicines that have been specifically developed and authorised for radiolabelling with lutetium chloride.

The committee recommended granting a conditional marketing authorisation for Kayshild (semaglutide), a GLP1 receptor agonist for the treatment of non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with liver fibrosis, a serious disease where fat deposits accumulate in the liver causing inflammation. There are currently several GLP1 receptor agonists approved in the EU to treat diabetes and weight management. This is the first GLP1 medicine approved in this indication.

The CHMP adopted a positive opinion under exceptional circumstances for Kygevvi (doxecitine / doxribtimine), the first treatment for thymidine kinase 2 deficiency, a rare, life-threatening genetic disease that affects fewer than one in a million people and for which there is no authorised treatment. Patients suffer from muscle weakness, loss of motor function, breathing difficulties and a shortened life expectancy. Current care is limited to supportive measures such as the use of feeding tubes, physiotherapy and respiratory ventilators. This medicine was supported through EMA's PRIority MEdicines (PRIME) scheme, which provides early and enhanced scientific and regulatory support for promising medicines with a potential to address unmet medical needs. See more details in the news announcement in the grid below.

The committee recommended granting a marketing authorisation for Supemtek (trivalent influenza vaccine (recombinant, prepared in cell culture)), a vaccine for the prevention of influenza in adults and children from nine years of age. This vaccine complies with the World Health Organisation (WHO) recommendation and the EU recommendation for the 2025/2026 season.

Outcome of re-examination

Following a re-examination, the committee recommended granting a conditional marketing authorisation for Rezurock (belumosudil), a medicine intended for the treatment of chronic graft-versus-host disease, a condition in which donor cells of a bone marrow or stem cell transplant attack the host body. The committee concluded that this medicine is to be used when other treatment options provide limited clinical benefit, are not suitable or have been exhausted. See more details in the news announcement in the grid below.

Recommendations on extensions of therapeutic indication for nine medicines

The committee recommended to extend the use of Zynyz (retifanlimab) for the treatment of adults with squamous cell carcinoma of the anal canal (SCAC) that cannot be removed by surgery and is metastatic or locally recurrent. There are currently no medicines specifically authorised in the EU for the treatment of adults with SCAC, the most common type of anal cancer, accounting for 85% of all cases. See more details in the news announcement in the grid below.

The CHMP adopted a positive opinion to extend the use of Eurneffy (epinephrine) with a new strength (1 mg nasal spray, solution) indicated for children from 4 years old with a body weight of 15 kg to less than 30 kg. Eurneffy is the first emergency treatment against allergic reactions that is administered as a nasal spray, not as an injection.

The committee recommended another seven extensions of indication for medicines that are already authorised in the EU: Akeega, Efmody, Iclusig, Imfinzi, Kerendia, Noxafil and Opdivo.

Start of referral

The committee started a review of Tavneos (avacopan), following emerging information that raises questions regarding the data integrity of the main study supporting the medicine’s marketing authorisation in the EU. Tavneos is a medicine indicated for the treatment of adults with severe, active granulomatosis with polyangiitis or microscopic polyangiitis, two rare inflammatory conditions of the blood vessels. The review of Tavneos was initiated at the request of the European Commission, under Article 20 of Regulation (EC) No 726/2004. For more information, see the start of referral communication in the grid below.

Other updates

The CHMP has finalised its assessment of an application to extend the use of Mounjaro (tirzepatide) to include treatment of symptomatic long-term (chronic) heart failure with preserved ejection fraction (HFpEF) in adults with obesity. Mounjaro is a medicine currently used together with diet and physical activity to help people lose weight and keep their weight under control. It is used in people who have obesity (BMI of 30 kg/m 2 or more) or who are overweight (BMI between 27 and 30 kg/m 2) and have weight-related health problems such as diabetes, abnormally high levels of fat in the blood, high blood pressure or obstructive sleep apnoea. Although EMA did not recommend that a separate indication should be granted for the treatment of HFpEF, it agreed to include relevant data from the study submitted with the application in the medicine’s product information. This ensures that healthcare professionals have access to up-to-date data on the effects of Mounjaro in adults with chronic HFpEF and obesity. For more information, see the question-and-answer document in the grid below.

Agenda and minutes

The agenda of the January 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 January 2026 CHMP meeting are represented in the graphic below.

CHMP statistics: Text version

January 2026 statistics - monthly and cumulative figures for CHMP opinions and withdrawn applications:

• 6 positive opinions on new medicines: 4 new non-orphan medicine, 2 orphan medicines, 0 biosimilars, and 0 generic, hybrid or informed consent medicine. Total in 2026: 6
• 0 negative opinions on new medicines. Total in 2026: 0
• 9 positive opinions on extensions of therapeutic indication. Total in 2026: 9
• 0 withdrawn applications for new medicines. Total in 2026: 0

Positive recommendations on new medicines

Fylrevy

International non-proprietary name (INN) estetrol

Marketing authorisation applicant Gedeon Richter Plc.

Therapeutic indication Hormone replacement therapy (HRT) for oestrogen deficiency symptoms in postmenopausal women.

More information Fylrevy: pending EC decision

Ilumira

INN lutetium (177Lu) chloride

Marketing authorisation applicant SHINE Europe B.V.

Therapeutic indication Used only for the radiolabelling of carrier molecules that have been specifically developed and authorised for radiolabelling with Lutetium (177Lu) chloride.

More information Ilumira: pending EC decision

Kayshild

INN semaglutide

Marketing authorisation applicant Novo Nordisk A/S

Therapeutic indication Treatment of non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with liver fibrosis stages F2 to F3.

More information Kayshild: pending EC decision

Kygevvi

INN doxecitine / doxribtimine

Marketing authorisation applicant UCB Pharma

Therapeutic indication Treatment of paediatric and adult patients with thymidine kinase 2 deficiency (TK2d) with an age of symptom onset on or before 12 years.

Orphan designation This medicine was designated an orphan medicine.

More information Kygevvi: pending EC decision

News announcement First treatment for rare thymidine kinase 2 deficiency

Supemtek

INN trivalent influenza vaccine (recombinant, prepared in cell culture)

Marketing authorisation applicant Sanofi Winthrop Industrie

Therapeutic indication Immunisation for the prevention of influenza disease.

More information Supemtek: pending EC decision

Positive recommendations on extensions of therapeutic indications

Akeega

INN niraparib / abiraterone acetate

Marketing authorisation holder Janssen Cilag International

More information Akeega: pending EC decision

Efmody

INN hydrocortisone

Marketing authorisation holder Neurocrine Netherlands B.V.

More information Efmody: pending EC decision

Eurneffy

INN epinephrine

Market authorisation holder Alk-Abello A/S

More information Eurneffy: pending EC decision

Iclusig

INN ponatinib

Marketing authorisation holder Incyte Biosciences Distribution B.V.

More information Iclusig: pending EC decision

Imfinzi

INN durvalumab

Marketing authorisation holder AstraZeneca AB

More information Imfinzi: pending EC decision

Kerendia

INN finerenone

Marketing authorisation holder Bayer AG

More information Kerendia: pending EC decision

Noxafil

INN posaconazole

Marketing authorisation holder Merck Sharp and Dohme B.V.

More information Noxafil: pending EC decision

Opdivo

INN nivolumab

Marketing authorisation holder Bristol-Myers Squibb Pharma EEIG

More information Opdivo: pending EC decision

Zynyz

INN retifanlimab

Marketing authorisation holder Incyte Biosciences Distribution B.V.

Orphan designation This medicine was designated an orphan medicine.

More information Zynyz: pending EC decision

News announcement First immunotherapy-based treatment recommended for advanced anal cancer

Outcome of re-examination on recommendation for new medicine

Rezurock

INN belumosudil

Marketing authorisation applicant Sanofi Winthrop Industrie

Orphan designation This medicine was designated an orphan medicine.

More information Rezurock: pending EC decision

News announcement New medicine to treat chronic graft-versus-host disease

Start of referral procedure

Tavneos

INN avacopan

More information Tavneos: Article 20 procedure

News announcement EMA starts review of Tavneos, a medicine for rare autoimmune diseases GPA and MPA

Other updates

Mounjaro

INN tirzepatide

Marketing authorisation holder Eli Lilly Nederland B.V.

More information Mounjaro

Scientific advice and protocol assistance adopted during the CHMP meeting 26-29 January 2026

Adopted Reference Number: EMA/39865/2026 English (EN) (261.33 KB - PDF)

First published:

17/02/2026

View Questions and answers on the outcome of assessment on use of Mounjaro in treatment of heart failure with preserved ejection fraction in adults with obesity

Reference Number: EMA/18704/2026 English (EN) (142.63 KB - PDF)

First published:

30/01/2026

View Start of Union reviews adopted during the CHMP meeting of 26-29 January 2026

Adopted Reference Number: EMA/18830/2026 English (EN) (111.11 KB - PDF)

First published:

30/01/2026

View Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 26-29 January 2026

Adopted Reference Number: EMA/18748/2026 English (EN) (207.85 KB - PDF)

First published:

18/12/2025

Last updated:

05/02/2026

View 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.

News

• First treatment for rare thymidine kinase 2 deficiency
• New medicine to treat chronic graft-versus-host disease
• EMA starts review of Tavneos, a medicine for rare autoimmune diseases GPA and MPA
• First immunotherapy-based treatment recommended for advanced anal cancer

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Related medicine information

• Fylrevy
• Ilumira
• Kayshild
• Kygevvi
• Supemtek
• Akeega
• Efmody
• Eurneffy
• Imfinzi
• Kerendia
• Noxafil
• Opdivo
• Zynyz
• Iclusig
• Rezurock
• Tavneos - referral
• Mounjaro

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