Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 15-18 September 2025

19 September 2025

14 new medicines recommended for approval; another six medicines recommended for extension of their therapeutic indications

14 new medicines recommended for approval

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:

• Acvybra (denosumab), Denosumab Intas (denosumab), Kefdensis (denosumab), and Ponlimsi (denosumab), for the treatment of osteoporosis and bone loss.
• Degevma (denosumab), Xbonzy (denosumab), and Zvogra (denosumab), for the prevention of skeletal-related events in adults and treatment of adults and skeletally-mature adolescents with giant cell tumour of bone.
• Gobivaz (golimumab), for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis and ulcerative colitis.
• Usgena (ustekinumab), for the treatment of Crohn’s disease, plaque psoriasis and paediatric plaque psoriasis, psoriatic arthritis, and ulcerative colitis.

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.

Recommendations on extensions of therapeutic indication for six medicines

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.

Withdrawal of applications

Applications for initial marketing authorisation for four medicines were withdrawn:

• Amtagvi (lifileucel), a medicine to treat melanoma that is unresectable (cannot be removed by surgery) or metastatic (has spread to other parts of the body) in adults.
• Fanskya (mozafancogene autotemcel), for the treatment of paediatric patients with Fanconi Anaemia Type A.
• Tuzodi (midazolam), for the treatment of prolonged, acute, convulsive seizures in adults, adolescents, children and toddlers from two years of age.
• Omforro (midazolam), for the conscious sedation before and during diagnostic or therapeutic procedures with or without local anaesthesia and premedication before induction of anaesthesia.

Question-and-answer documents on the withdrawals of these medicines are available in the grid below.

Outcome of re-examination

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.

Other updates

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).

Agenda and minutes

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.

CHMP statistics

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.

CHMP statistics

CHMP statistics: Text version

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

Positive recommendations on new medicines

Enflonsia

• International non-proprietary name (INN):

  clesrovimab

• Marketing authorisation applicant:

  Merck Sharp & Dohme B.V.

• Therapeutic indication:

  Prevention of infections with respiratory syncytial virus (RSV) and lower respiratory tract disease (LRTD)

• More information:

  Enflonsia: pending EC decision

Imaavy

• INN:

  nipocalimab

• Marketing authorisation applicant:

  Janssen Cilag International NV

• Therapeutic indication:

  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.

• More information:

  Imavvy: pending EC decision

Kyinsu

• INN:

  insulin icodec / semaglutide

• Marketing authorisation applicant:

  Novo Nordisk A/S

• Therapeutic indication:

  Treatment of adults with type 2 diabetes mellitus insufficiently controlled on basal insulin or glucagon-like peptide 1 (GLP-1) receptor agonists

• More information:

  Kyinsu: pending EC decision

Lynkuet

• INN:

  elinzanetant

• Marketing authorisation applicant:

  Bayer AG

• Therapeutic indication:

  Treatment of moderate to severe vasomotor symptoms (VMS)

• More information:

  Lynkuet: pending EC decision

Positive recommendations on new biosimilar medicines

Acvybra

• INN:

  Denosumab

• Marketing authorisation applicant:

  Reddy Holding GmbH

• Therapeutic indication:

  Treatment of osteoporosis and bone loss

• More information:

  Acvybra: pending EC decision

Degevma

• INN:

  denosumab

• Marketing authorisation applicant:

  TEVA GmbH

• Therapeutic indication:

  Prevention of skeletal related events in adults and treatment of adults and skeletally mature adolescents with giant cell tumour of bone

• More information:

  Degevma: pending EC decision

Denosumab Intas

• INN:

  denosumab

• Marketing authorisation applicant:

  Intas Third Party Sales 2005 S.L.

• Therapeutic indication:

  Treatment of osteoporosis and bone loss

• More information:

  Denosumab Intas: pending EC decision

Gobivaz

• INN:

  golimumab

• Marketing authorisation applicant:

  Advanz Pharma Limited

• Therapeutic indication:

  Treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis and ulcerative colitis

• More information:

  Gobivaz: pending EC decision

Kefdensis

• INN:

  denosumab

• Marketing authorisation applicant:

  STADA Arzneimittel AG

• Therapeutic indication:

  Treatment of osteoporosis and bone loss

• More information:

  Kefdensis: pending EC decision

Ponlimsi

• INN:

  denosumab

• Marketing authorisation applicant:

  Teva GmbH

• Therapeutic indication:

  Treatment of osteoporosis and bone loss

• More information:

  Ponlimsi: pending EC decision

Usgena

• INN:

  ustekinumab

• Marketing authorisation applicant:

  Stada Arzneimittel AG

• Therapeutic indication:

  Treatment of Crohn’s disease, plaque psoriasis and paediatric plaque psoriasis, psoriatic arthritis, and ulcerative colitis.

• More information:

  Usgena: pending EC decision

Xbonzy

• INN:

  denosumab

• Marketing authorisation applicant:

  Reddy Holding GmbH

• Therapeutic indication:

  Prevention of skeletal related events in adults and treatment of adults and skeletally mature adolescents with giant cell tumour of bone

• More information:

  Xbonzy: pending EC decision

Zvogra

• INN:

  denosumab

• Marketing authorisation applicant:

  Stada Arzneimittel AG

• Therapeutic indication:

  Prevention of skeletal related events in adults and treatment of adults and skeletally mature adolescents with giant cell tumour of bone

• More information:

  Zvogra: pending EC decision

Positive recommendations on new generic medicines

Rivaroxaban Koanaa

• INN:

  rivaroxaban

• Marketing authorisation applicant:

  Koanaa Healthcare Spain S.L.

• Therapeutic indication:

  Prevention of atherothrombotic events

• More information:

  Rivaroxaban Koanaa: pending EC decision

Positive recommendations on extensions of therapeutic indications

Bimervax

• INN:

  COVID-19 vaccine

• Marketing authorisation holder:

  Hipra Human Health S.L.

• More information:

  Bimervax: pending EC decision

Dupixent

• INN:

  dupilumab

• Marketing authorisation holder:

  sanofi-aventis groupe

• More information:

  Dupixent: pending EC decision

Keytruda

• INN:

  pembrolizumab

• Marketing authorisation holder:

  Merck Sharp & Dohme Limited

• More information:

  Keytruda: pending EC decision; Keytruda: pending EC decision

Koselugo

• INN:

  selumetinib

• Marketing authorisation holder:

  AstraZeneca AB

• More information:

  Koselugo: pending EC decision

Tezspire

• INN:

  tezepelumab

• Market authorisation holder:

  AstraZeneca AB

• More information:

  Tezspire: pending EC decision

Uplizna

• INN:

  inebilizumab

• Marketing authorisation holder:

  Amgen Europe B.V.

• More information:

  Uplizna: pending EC decision

• News announcement:

  First treatment recommended for rare immunoglobulin-related autoimmune disease

Recommendation on new contraindication

Remsima

• INN:

  infliximab

• Marketing authorisation holder:

  Celltrion Healthcare Hungary Kft.

• More information:

  Remsima: pending EC decision

Withdrawal of initial marketing authorisation application

Fanskya

• INN:

  mozafancogene autotemcel

• Market authorisation applicant:

  Rocket Pharmaceuticals B.V.

• Therapeutic indication:

  For the treatment of paediatric patients with Fanconi Anaemia Type A

• More information:

  Fanskya: withdrawn application

Amtagvi

• INN:

  lifileucel

• Market authorisation applicant:

  Iovance Biotherapeutics B.V.

• Therapeutic indication:

  Treatment of unresectable or metastatic melanoma

• More information:

  Amtagvi: withdrawn application

Tuzodi

• INN:

  Midazolam

• Marketing authorisation applicant:

  Regulatory Pharma Net S.r.l.

• Therapeutic indication:

  Treatment of prolonged, acute, convulsive seizures in adults, adolescents, children and toddlers (from 2 years of age).;

• More information:

  Tuzodi: withdrawn application

Omforro

• INN:

  Midazolam

• Marketing authorisation applicant:

  Regulatory Pharma Net S.r.l.

• Therapeutic indication:

  Conscious sedation before and during diagnostic or therapeutic procedures with or without local anaesthesia and premedication before induction of anaesthesia

• More information:

  Omforro: withdrawn application

Re-examinations of initial applications

Atropine sulfate FGK

• INN:

  atropine

• Marketing authorisation applicant:

  FGK Representative Service GmbH

• Therapeutic indication:

  Treatment of myopia in children aged 3 years and older

• More information:

  Atropine sulfate FGK: pending EC decision

Winlevi

• INN:

  clascoterone

• Marketing authorisation applicant:

  Cassiopea S.p.A.

• Therapeutic indication:

  For the topical treatment of acne vulgaris in adults and adolescents

• More information:

  Winlevi: pending EC decision

Other updates

Questions and answer on the outcome of assessment on use of Lutathera in treatment of gastro-entero-pancreatic neuroendocrine tumours in adolescents

Reference Number: EMA/299422/2025

Recommendations on eligibility to PRIME scheme adopted at the CHMP meeting of 15-18 September 2025

Adopted Reference Number: EMA/290349/2025

Scientific advice and protocol assistance adopted during the CHMP meeting 15-18 September 2025

Reference Number: EMA/289375/2025

Lunsumio

• INN:

  mosunetuzumab

• Marketing authorisation holder:

  Roche Registration GmbH

• More information:

  Lunsumio: pending EC decision

Norvir

• INN:

  ritonavir

• Market authorisation holder:

  AbbVie Deutschland GmbH Co. KG

• More information:

  Norvir: pending EC decision