CHMP Meeting Highlights January 2026 New
This month, medicinal products for the following indications have received a positive opinion:
- hormone replacement therapy for oestrogen deficiency symptoms
- non-cirrhotic metabolic dysfunction-associated steatohepatitis
- thymidine kinase 2 deficiency
- chronic graft-versus-host disease
- influenza vaccine
New medicines recommended for approval:
Fylrevy (esterol): has received a positive opinion for the hormone replacement therapy (HRT) for oestrogen deficiency symptoms in hysterectomised postmenopausal women or in non-hysterectomised postmenopausal women with at least 12 months since last menses.
Estetrol, a sex hormone and modulator of the genital system, substitutes for the loss of oestrogen production in women who have gone through the menopause and alleviates symptoms associated with the menopause. For more information please consult the product for Fylrevy on the EMA website.
Ilumira (lutetium (177Lu) chloride): has received a positive opinion for the radiolabelling of carrier molecules that have been specifically developed and authorised for radiolabelling with lutetium (177Lu) chloride. Ilumira is a radiopharmaceutical precursor, and it is not intended for direct use in patients. For more information please consult the product for Ilumira on the EMA website.
Kayshild (semaglutide): has received a positive opinion for the conditional marketing authorisation for the treatment in conjunction with diet and exercise of adults with non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver fibrosis (fibrosis stages F2 to F3).
MASH is a chronic liver disease characterized by excessive fat build-up in the liver and subsequent scarring of the liver. Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist. This is a natural hormone in your body that plays a role in regulating blood sugar, appetite, and digestion. Semaglutide mimics GLP-1 by binding to the receptor. It is already authorized for weight management and type 2 diabetes. For more information please consult the product for Kayshild on the EMA website.
Kygevvi (doxecitine/doxribtimine): has received a positive opinion for a marketing authorisation under exceptional circumstances for the treatment of paediatric and adult patients with genetically confirmed thymidine kinase 2 deficiency (TK2d) with an age of symptom onset on or before 12 years.
TK2 deficiency is a rare inherited metabolic disorder. It's caused by a mutation in the TK2 gene, which provides instructions for making an enzyme called thymidine kinase 2. This enzyme is crucial for the proper functioning of mitochondria, the "powerhouses" of cells. TK2 is essential for the synthesis of mtDNA. Doxecitine and Doxribitimine are deoxynucleosides that can be used for the synthesis of mtDNA. A news announcement was release by the EMA for this product. For more information please consult the product for Kygevvi on the EMA website.
Rezurock (belumosudil): has received a positive opinion for the conditional marketing authorisation for the treatment of adults and paediatric patients (12 years and older with a body weight of at least 40 kg) with chronic graft-versus-host disease (cGVHD) when other treatment options provide limited clinical benefit, are not suitable, or have been exhausted.
cGVHD is a complex, multi-organ systemic disease that occurs after allogeneic stem cell transplantation. It's characterized by immune dysregulation and inflammation, leading to a wide range of symptoms. Rezurock is an inhibitor of the Rho-associated coiled-coil kinase 2 (ROCK2). ROCK2 mediated pathways are part in pro- and anti-inflammatory immune cell responses. In addition, ROCK2 mediates stress fiber formation and regulates the transcription of pro-fibrotic genes. A news announcement was release by the EMA for this product. For more information please consult the product for Rezurock on the EMA website.
Supemtek (trivalent influenza vaccine (recombinant, prepared in cell culture): has received a positive opinion for the active immunization for the prevention of influenza disease in adults and children from 9 years of age and older.
Supemtek is a seasonal trivalent influenza vaccine, which means it contains three different Hemagglutinin antigens of different influenza strains namely A/H1N1, A/H3N2 and B/Victoria. In 2020 Supemtek Tetra – a quadrivalent vaccine – received a marketing authorisation. It contains additionally Hemagglutinin antigens from the B/Yamagata strain. As this strain isn’t circulating since March 2020 the WHO and EMA recommend the removal of B/Yamagata antigens from seasonal influenza vaccines, which lead to this trivalent Supemtek variant. For more information please consult the product for Supemtek on the EMA website.
Recommendations on extensions of therapeutic indication:
Akeega (niraparib / abiraterone acetate): extension of indication for Akeega to include with prednisone or prednisolone in combination with androgen deprivation therapy (ADT) the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC) and BRCA 1/2 mutations (germline and/or somatic).
It is already authorised with prednisone or prednisolone for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) and BRCA 1/2 mutations (germline and/or somatic) in whom chemotherapy is not clinically indicated. For more information please consult the product for Akeega on the EMA website.
Efmody (hydrocortisone): extension of indication for Efmody to include the treatment of adrenal insufficiency in adolescents aged 12 years and over and adults. It is already authorised for the treatment of congenital adrenal hyperplasia. For more information please consult the product for Efmody on the EMA website.
Eurneffy (epinephrine): extension of indication for Eurneffy to include the treatment of allergic reactions (anaphylaxis) due to insect stings or bites, foods, medicinal products and other allergens as well as idiopathic or exercise induced anaphylaxis. Treatment is indicated for adults and children aged 4 years and older with a body weight of 15 kg or greater. Previously it was only authorised for adults and children weighing at least 30 kg. For more information please consult the product for Eurneffy on the EMA website.
Iclusig (ponatinib): extension of indication for Iclusig to include in combination with chemotherapy the treatment of adult patients with newly diagnosed Ph+ ALL. It is already authorised for the treatment of Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) and chronic myeloid leukaemia in a later-line setting. For more information please consult the product for Iclusig on the EMA website.
Imfinzi (durvalumab): extension of indication for Imfimzi to include in combination with FLOT chemotherapy as neoadjuvant and adjuvant treatment, followed by adjuvant IMFINZI monotherapy, is indicated for the treatment of adults with resectable gastric or gastro-oesophageal junction adenocarcinoma. It is already authorised for other kinds of cancer and settings. For more information please consult the product for Imfinzi on the EMA website.
Kerendia (finerenone): extension of indication for Kerendia to include the treatment of symptomatic chronic heart failure with left ventricular ejection fraction (LVEF) ≥ 40% in adults. It is already authorised for the treatment of chronic kidney disease associated with type 2 diabetes in adults. For more information please consult the product for Kerendia on the EMA website.
Noxafil (Posaconazole): extension of indication for Noxafil to include the treatment of several invasive fungal infections in adults and paediatric patients from 2 years of age weighing more than 40 kg. Previously it was only authorised fo prophylaxis and treatment of the same invasive fungal infections after failed treatment with amphotericin B or itraconazole. For more information please consult the product for Noxafil on the EMA website.
Opdivo (nivolumab): extension of indication for Opdivo to include the treatment in combination with brentuximab vedotin of children 5 years of age and older, adolescents and adults up to 30 years of age with relapsed or refractory classical Hodgkin lymphoma after one prior line of therapy. Is already authorised for the different of other kinds of cancer and settings. For more information please consult the product for Opdivo on the EMA website.
Zynyz (retifanlimab): extension of indication for Zynyz to include in combination with carboplatin and paclitaxel the first-line treatment of adult patients with metastatic or with inoperable locally recurrent squamous cell carcinoma of the anal canal (SCAC). It is already authorised for the treatment of Merkel cell carcinoma. A news announcement was release by the EMA for this product. For more information please consult the product for Zynyz on the EMA website.
Newly published EPARs:
The EPAR (European public assessment report) is the main document where the EMA publishes detailed information on the medicines assessed by the CHMP. Below is a list of the EPARs for recently approved products that have been made available on the EMA homepage:
Austedo: is indicated for the treatment of moderate to severe tardive dyskinesia in adults. EPAR Austedo.
Inluriyo: is indicated as monotherapy for the treatment of adult patients with oestrogen receptor (ER) positive, HER2-negative, locally advanced or metastatic breast cancer with an activating ESR1 mutation, who have disease progression following prior treatment with an endocrine based regimen. EPAR Inluriyo.
VacPertagen: is indicated for:
- booster immunisation against pertussis of individuals 12 years of age and older,
- passive protection against pertussis in early infancy following maternal immunisation during pregnancy
Wayrilz: is indicated for the treatment of immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments. EPAR Wayrilz.
Previous CHMP Meeting Highlights can be accessed at: https://www.basg.gv.at/en/healthcare-professionals/chmp-highlights
