CHMP Meeting Highlights December 2025
This month, medicinal products for the following indications have received a positive opinion:
- BCG-unresponsive non-muscle invasive bladder cancer
- non-small cell lung cancer
- severe eosinophilic asthma
- severe chronic rhinosinusitis with nasal polyps
- obstructive hypertrophic cardiomyopathy
- COVID-19 vaccine
New medicines recommended for approval:
Anktiva (nogapendekin alfa inbakicept): has received a positive opinion for the conditional marketing authorisation for the treatment in combination with Bacillus Calmette-Guérin (BCG) of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumours.
NMIBC is a type of cancer that affects the lining of the bladder with a risk of spreading and growing. Anktiva activates the immune system to destroy the cancer cells by binding to the interleukin 15 (IL-15). A news announcement was release by the EMA for this product. For more information please consult the product for Anktiva on the EMA website.
Aumseqa (aumolertinib): has received a positive opinion for the treatment the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations and the treatment of adult patients with advanced EGFR T790M mutation-positive NSCLC.
NSCLC is a serious and often fatal disease that accounts for 80 to 85% of all lung cancers. A significant number of patients present with driver mutations in oncogenes, some of which can be aimed at by targeted therapies. Patients without known driver mutations need broader-acting therapies.
Aumseqa is an inhibitor the mutated epidermal growth factor receptor (EGFR). EGFR interacts with different signal pathways, which regulate cell proliferation and programmed cell death. By blocking EGFR the cell proliferation of the tumour slows. For more information please consult the product for Aumseqa on the EMA website.
Exdensur (depemokimab): has received a positive opinion as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by blood eosinophil count in adults and adolescents 12 years and older who are inadequately controlled despite high dose inhaled corticosteroids (ICS) plus another asthma controller.
It also received a positive opinion for add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe chronic rhinosinusitis with nasal polyps for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control.
Asthma is a chronic inflammatory disease of the airways characterised by airflow obstruction and bronchospasms. Although the etiology of the disease is unknown, environmental, genetic and psychogenic factors seem to contribute. Eosinophilic asthma is characterized by increased eosinophils (a type of white blood cells) in the airways.
Chronic rhinosinusitis is a persistent infection of the nasal mucosa and the paranasal sinuses. Exdensur is a monoclonal antibody targeting Interleukin 5 (IL-5). IL-5 is part of the type 2 inflammation of the immune system and promotes the production of eosinophils and trafficking of these to the site of the infection. For more information please consult the product for Exdensur on the EMA website.
Myqorzo (aficamten): has received a positive opinion for the treatment of symptomatic (New York Heart Association, NYHA, class II-III) obstructive hypertrophic cardiomyopathy (oHCM) in adult patients.
oHCM is a disease in which the heart muscle becomes thickened, impairing the blood-pumping and electrical conduction function of the heart. HCM is classified as obstructive when the outflow of blood from the left ventricle is obstructed. Myqorzo inhibits cardiac myosin, which is responsible for the contraction of the heart. For more information please consult the product for Myqorzo on the EMA website.
mNexspike (COVID-19 mRNA vaccine): has received a positive opinion for the active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older.
COVID-19 or Coronavirus disease 2019, is a contagious disease caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Although this virus can infect a wide variety of cells, it is most known for causing respiratory tract symptoms, which vary from mild to severe. The virus enters the cells mainly by binding to the angiotensin converting enzyme 2 (ACE2). For more information please consult the product for mNexspike on the EMA website.
Recommendations on extensions of therapeutic indication:
Arexvy (respiratory syncytial virus (RSV) vaccine (recombinant, adjuvanted)): extension of indication for Arexvy to include the active immunisation for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus in adults 18 years of age and older. Previously Arexvy was only authorised für adults 60 years and older or 50 years if the person was at increased risk for RSV disease. For more information please consult the product for Arexvy on the EMA website.
Aspaveli (pegcetacoplan): extension of indication for Aspaveli to include the treatment of adult and adolescent patients aged 12 to 17 years with C3 glomerulopathy (C3G) or primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN) in combination with a renin-angiotensin system (RAS) inhibitor, unless RAS inhibitor treatment is not tolerated or contraindicated.
Aspaveli ist already authorised for the treatment of adult patients with paroxysmal nocturnal haemoglobinuria. For more information please consult the product for Aspaveli on the EMA website.
Dovprela (pretomanid): extension of indication for Dovprela to include the treatment adults with pulmonary tuberculosis (TB) due to Mycobacterium tuberculosis resistant to rifampicin, with or without resistance to isoniazid in combination with bedaquiline and linezolid. For more information please consult the product for Dovprela on the EMA website.
Elucirem / Vueway (gadopiclenol): extension of indication for Elucirem / Vueway to include adults and children from birth for contrast-enhanced magnetic resonance imaging (MRI) to improve detection and visualization of pathologies with disruption of the blood-brain-barrier (BBB) and/or abnormal vascularity of:
- the brain, spine, and associated tissues of the central nervous system (CNS);
- the liver, kidney, pancreas, breast, lung, prostate, and musculoskeletal system.
Previously the age limit was 2 years. For more information please consult the product for Elucirem on the EMA website.
Eylea (aflibercept): extension of indication for Eylea to include the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch, central and hemiretinal RVO). Eylea is already authorised for the treatment of age related macular degeneration and diabetic macular oedema. For more information please consult the product for Eylea on the EMA website.
Mounjaro (tirzepatide): extension of indication for Mounjaro to include the treatment of adults, adolescents and children aged 10 years and above with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise
- as monotherapy when metformin is considered inappropriate due to intolerance or contraindications
- in addition to other medicinal products for the treatment of diabetes.
Previously Mounjaro was only authorised for the treatment of type 2 diabetes in adults. For more information please consult the product for Mounjaro on the EMA website.
Nucala (mepolizumab): extension of indication for Nucala to include the add-on maintenance treatment for uncontrolled chronic obstructive pulmonary disease (COPD) characterised by raised blood eosinophils on a combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA), and a long-acting muscarinic antagonist (LAMA). Nucala is already authorised for the treatment of severe eosinophilic asthma, chronic rhinosinusitis with nasal polyps, eosinophilic granulomatosis with polyangiitis and hypereosinophilic syndrome. For more information please consult the product for Nucala on the EMA website.
Recarbrio (imipenem / cilastatin / relebactam): extension of indication for Recarbrio to include the treatment of
- hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP)
- bacteraemia that occurs in association with, or is suspected to be associated with HAP or VAP
- infections due to aerobic Gram-negative organisms in adults with limited treatment options
in adult and paediatric patients from birth. Previously Recarbrio was only authorised for the treatment of adult patients. For more information please consult the product for Recarbrio on the EMA website.
Simponi (golimumab): extension of indication for Simponi to include the treatment of moderately to severely active ulcerative colitis in paediatric patients 2 years of age and older with a body weight of at least 15 kg, who have had an inadequate response to conventional therapy, including corticosteroids and 6‑mercaptopurine (6‑MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Simpoii is already authorised for the treatment of ulcerative colitis in adult patients. For more information please consult the product for Simponi on the EMA website.
Uplizna (inebilizumab): extension of indication for Uplizna to include as an add-on to standard therapy for the treatment of gMG in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive. Upllizna is already authorised for the treatment of Immunoglobulin G4-related disease and neuromyelitis optica spectrum disorders. For more information please consult the product for Uplizna on the EMA website.
Winrevair (sotatercept): extension of indication for Winrevair to include the treatment of PAH in adult patients with WHO Functional Class (FC) II to IV in combination with other pulmonary arterial hypertension (PAH) therapies. Previously Winrevair was only authorised for the treatment of PAH patients with functional class II and III. For more information please consult the product for Winrevair 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:
Brinsupri: is indicated for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in patients 12 years of age and older with two or more exacerbations in the prior 12 months. EPAR Brinsupri.
Imaavy: is indicated as an add-on to standard therapy for the treatment of generalised Myasthenia Gravis (gMG) in adult and adolescent patients aged 12 years of age and older who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive. EPAR Imaavy.
Lynkuet: is indicated for the treatment of moderate to severe vasomotor symptoms (VMS):
- associated with menopause
- caused by adjuvant endocrine therapy (AET) related to breast cancer.
Previous CHMP Meeting Highlights can be accessed at: https://www.basg.gv.at/en/healthcare-professionals/chmp-highlights
