EMA’s human medicines committee (CHMP) recommended 14 medicines for approval at its September 2025 meeting.
The committee recommended granting a marketing authorisation for Enflonsia (clesrovimab), a medicine indicated for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants. RSV is a common respiratory virus that usually causes symptoms similar to the common cold but can also affect the lungs. Almost all children get an RSV infection by the time they are two years old. While most recover quickly, in some children RSV can cause severe illness that may lead to hospitalisation and even death.
The CHMP recommended granting a marketing authorisation for Imaavy (nipocalimab), for the treatment of generalised myasthenia gravis, a disease that leads to muscle weakness and tiredness.
A positive opinion was adopted for Kyinsu (insulin icodec / semaglutide), for the treatment of adults with type 2 diabetes insufficiently controlled on basal insulin or glucagon-like peptide 1 (GLP-1) receptor agonists. Kyinsu is used together with diet, exercise and oral medicines to treat diabetes.
Lynkuet (elinzanetant) received a positive opinion from the CHMP for the treatment of moderate-to-severe vasomotor symptoms, also referred to as hot flushes or night sweats, associated with menopause.
The committee adopted positive opinions for nine biosimilar medicines:
A generic medicine, Rivaroxaban Koanaa (rivaroxaban), received a positive opinion for the prevention of venous thromboembolism, the treatment and prevention of deep vein thrombosis and pulmonary embolism, and the prevention of stroke and systemic embolism in adults with various risk factors for such events, as well as the treatment and prevention of venous thromboembolism in children and adolescents.
The committee recommended extending the therapeutic indication of Uplizna (inebilizumab), a medicine used to treat adults with neuromyelitis optica spectrum disorders, to include the treatment of active immunoglobulin G4-related disease, a rare autoimmune disease for which currently there are no authorised medicines in the EU. See more details in the news announcement in the grid below.
The committee recommended another five extensions of indication for medicines that are already authorised in the EU: Bimervax, Dupixent, Keytruda, Koselugo, and Tezspire.
For Keytruda, the committee also recommended a new pharmaceutical form and a new strength for subcutaneous administration.
Applications for initial marketing authorisation for four medicines were withdrawn:
Question-and-answer documents on the withdrawals of these medicines are available in the grid below.
Following a re-examination, the committee recommended granting a marketing authorisation for Winlevi (clascoterone), a medicine intended for the topical treatment of acne vulgaris in adults and adolescents. The positive opinion was adopted in August 2025.
After a re-examination of its initial opinion at the request of the applicant, the CHMP confirmed its initial recommendation to refuse the marketing authorisation for Atropine sulfate FGK (atropine sulfate), a medicine intended for the treatment of myopia (short-sightedness) in children aged 6 to 10 years.
For more information, see the question-and-answer documents in the grid below.
The CHMP gave a positive opinion to update the composition of the vaccine Bimervax to target the new SARS-CoV-2 LP.8.1 variant of the virus that causes COVID-19. The revision of this vaccine is in line with the recommendation issued by EMA’s Emergency Task Force to update COVID-19 vaccines to target the SARS-CoV-2 variant LP.8.1 for the 2025/2026 vaccination campaign.
The committee adopted a new route of administration for Lunsumio, a cancer medicine used to treat adults with follicular lymphoma that does not respond to (refractory) or has come back (relapsed) after at least two previous treatments.
The CHMP finalised its assessment of an application to extend the use of Lutathera* (lutetium (177Lu) oxodotreotide), a cancer medicine for treating tumours in the gut, to adolescents aged 12 years and older with unresectable or metastatic, somatostatin receptor-positive gastro-entero-pancreatic neuroendocrine tumours. Although EMA did not recommend this use, it agreed that relevant data from the study submitted with the application be included in the medicine’s product information so that healthcare professionals have access to up-to-date information. A question-and-answer document on the update is available in the grid below.
The CHMP also adopted a change to the existing indication and contraindications of Norvir (ritonavir), a medicine to treat patients who are infected with human immunodeficiency virus type 1 (HIV 1), a virus that causes acquired immune deficiency syndrome (AIDS).
The agenda of the September 2025 CHMP meeting is published on EMA's website. Minutes of the meeting will be published in the coming weeks.
Key figures from the September 2025 CHMP meeting are represented in the graphic below.
*This product was designated as an orphan medicine during its development. Orphan designations are reviewed by EMA's Committee for Orphan Medicinal Products (COMP) at the time of approval to determine whether the information available to date allows maintaining the medicine’s orphan status and granting the medicine ten years of market exclusivity.
September 2025 statistics - monthly and cumulative figures for CHMP opinions and withdrawn applications:
14 positive opinions on new medicines: 4 new non-orphan medicines, 0 orphan medicines, 9 biosimilars, and 1 generic, hybrid or informed consent medicine. Total in 2025: 85
0 negative opinions on new medicines. Total in 2025: 5
6 positive opinions on extensions of therapeutic indication. Total in 2025: 65
4 withdrawn applications for new medicines. Total in 2025: 17
clesrovimab
Merck Sharp & Dohme B.V.
Prevention of infections with respiratory syncytial virus (RSV) and lower respiratory tract disease (LRTD)
nipocalimab
Janssen Cilag International NV
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.
insulin icodec / semaglutide
Novo Nordisk A/S
Treatment of adults with type 2 diabetes mellitus insufficiently controlled on basal insulin or glucagon-like peptide 1 (GLP-1) receptor agonists
elinzanetant
Bayer AG
Treatment of moderate to severe vasomotor symptoms (VMS)
Denosumab
Reddy Holding GmbH
Treatment of osteoporosis and bone loss
denosumab
TEVA GmbH
Prevention of skeletal related events in adults and treatment of adults and skeletally mature adolescents with giant cell tumour of bone
denosumab
Intas Third Party Sales 2005 S.L.
Treatment of osteoporosis and bone loss
golimumab
Advanz Pharma Limited
Treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis and ulcerative colitis
denosumab
STADA Arzneimittel AG
Treatment of osteoporosis and bone loss
denosumab
Teva GmbH
Treatment of osteoporosis and bone loss
ustekinumab
Stada Arzneimittel AG
Treatment of Crohn’s disease, plaque psoriasis and paediatric plaque psoriasis, psoriatic arthritis, and ulcerative colitis.
denosumab
Reddy Holding GmbH
Prevention of skeletal related events in adults and treatment of adults and skeletally mature adolescents with giant cell tumour of bone
denosumab
Stada Arzneimittel AG
Prevention of skeletal related events in adults and treatment of adults and skeletally mature adolescents with giant cell tumour of bone
rivaroxaban
Koanaa Healthcare Spain S.L.
Prevention of atherothrombotic events
COVID-19 vaccine
Hipra Human Health S.L.
dupilumab
sanofi-aventis groupe
pembrolizumab
Merck Sharp & Dohme Limited
selumetinib
AstraZeneca AB
tezepelumab
AstraZeneca AB
inebilizumab
Amgen Europe B.V.
infliximab
Celltrion Healthcare Hungary Kft.
mozafancogene autotemcel
Rocket Pharmaceuticals B.V.
For the treatment of paediatric patients with Fanconi Anaemia Type A
lifileucel
Iovance Biotherapeutics B.V.
Treatment of unresectable or metastatic melanoma
Midazolam
Regulatory Pharma Net S.r.l.
Treatment of prolonged, acute, convulsive seizures in adults, adolescents, children and toddlers (from 2 years of age).
Midazolam
Regulatory Pharma Net S.r.l.
Conscious sedation before and during diagnostic or therapeutic procedures with or without local anaesthesia and premedication before induction of anaesthesia
atropine
FGK Representative Service GmbH
Treatment of myopia in children aged 3 years and older
clascoterone
FGK Representative Service GmbH
For the topical treatment of acne vulgaris in adults and adolescents
mosunetuzumab
Roche Registration GmbH
ritonavir
AbbVie Deutschland GmbH Co. KG