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 who have had a hysterectomy. 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 (177Lu) 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.
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.
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 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.
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.
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/m2 or more) or who are overweight (BMI between 27 and 30 kg/m2) 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.
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.
Key figures from the January 2026 CHMP meeting are represented in the graphic below.
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
estetrol
Gedeon Richter Plc.
Hormone replacement therapy (HRT) for oestrogen deficiency symptoms in postmenopausal women.
lutetium (177Lu) chloride
SHINE Europe B.V.
Used only for the radiolabelling of carrier molecules that have been specifically developed and authorised for radiolabelling with Lutetium (177Lu) chloride.
semaglutide
Novo Nordisk A/S
Treatment of non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with liver fibrosis stages F2 to F3.
doxecitine / doxribtimine
UCB Pharma
Treatment of paediatric and adult patients with thymidine kinase 2 deficiency (TK2d) with an age of symptom onset on or before 12 years.
This medicine was designated an orphan medicine.
trivalent influenza vaccine (recombinant, prepared in cell culture)
Sanofi Winthrop Industrie
Immunisation for the prevention of influenza disease.
niraparib / abiraterone acetate
Janssen Cilag International
hydrocortisone
Neurocrine Netherlands B.V.
epinephrine
Alk-Abello A/S
ponatinib
Incyte Biosciences Distribution B.V.
durvalumab
AstraZeneca AB
finerenone
Bayer AG
posaconazole
Merck Sharp and Dohme B.V.
nivolumab
Bristol-Myers Squibb Pharma EEIG
retifanlimab
Incyte Biosciences Distribution B.V.
This medicine was designated an orphan medicine.
belumosudil
Sanofi Winthrop Industrie
This medicine was designated an orphan medicine.
avacopan
tirzepatide
Eli Lilly Nederland B.V.