CHMP Meeting Highlights September 2025
This month, medicinal products for the following indications have received a positive opinion:
- RSV lower respiratory tract disease
- type 2 diabetes mellitus
- generalised Myasthenia Gravis
- vasomotor symptoms caused by menopause or adjuvant endocrine therapy
New medicines recommended for approval:
Enflonsia (clesrovimab): has received a positive opinion for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants during their first RSV season.
Respiratory Syncytial Virus (RSV) is a single-stranded RNA virus that causes the majority of cases of respiratory hospitalisation in infants. In the elderly population, approximately 15% of acute respiratory infections due to RSV lead to hospitalisation. Lower respiratory tract disease is characterised by bronchiolitis and pneumonia, and is potentially life-threatening. For more information please consult the product for Enflonsia on the EMA website.
Imaavy (Nipocalimab): has received a positive opinion 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.
gMG is a rare autoimmune disorder that causes muscle weakness. Around 90% of patients have detectable levels of autoantibodies in serum and the most common target AChR at the neuromuscular junction (NMJ), leading to failure of neuromuscular transmission. Imaavy is a monoclonal antibody which targets the neonatal Fc receptor (FcRn). Thus, the binding of IgG antibodies to FcRn is suppressed and the intracellular degradation of the pathogenic autoantibodies is stimulated. For more information please consult the product for Imaavy on the EMA website.
Kyinsu (Insulin icodec / Semaglutide): has received a positive opinion for the treatment of adults with type 2 diabetes mellitus insufficiently controlled on basal insulin or glucagon-like peptide 1 (GLP-1) receptor agonists as an adjunct to diet and exercise in addition to oral antidiabetic medicinal products. For more information please consult the product for Kyinsu on the EMA website.
Lynkuet (Elinzanetant): has received a positive opinion for the treatment of moderate to severe vasomotor symptoms (VMS):
- associated with menopause
- caused by adjuvant endocrine therapy (AET) related to breast cancer.
Vasomotor symptoms are commonly associated with menopause in women but can also be caused by other hormonal changes like endocrine therapy in breast cancer. The most common and well-known symptoms are hot flashes and night sweats, caused by hyperactive neurons in the hypothalamus. Lynkuet is Neurokinin-1- and Neurokinin-3 receptor antagonist. It blocks these receptors in hypothalamus and thus downregulates the hyperactive neurons. For more information please consult the product for Lynkuet on the EMA website.
Recommendations on extensions of therapeutic indication:
Bimervax (COVID-19 vaccine (recombinant, adjuvanted)): extension of indication for Bimervax to include as a booster the active immunisation to prevent COVID-19 in individuals 12 years of age and older who have previously received a mRNA COVID-19 vaccine. For more information please consult the product for Bimervax on the EMA website.
Dupixent (Dupilumab): extension of indication for Dupixent to include the treatment of moderate to severe chronic spontaneous urticaria (CSU) in adult and adolescent (12 years and above) patients with inadequate response to H1 antihistamines and who are naive to anti-IgE therapy for CSU. Dupixent is already authorised for the treatment of atopic dermatitis and asthma. For more information please consult the product for Dupixent on the EMA website.
Keytruda (Pembrolizumab): extension of indication for Keytruda to include the treatment of resectable locally advanced head and neck squamous cell carcinoma as neoadjuvant treatment, continued as adjuvant treatment in combination with radiation therapy with or without concomitant cisplatinum and then as monotherapy in adults whose tumours express PD-L1 with a CPS ≥ 1.
Keytruda has received a positive opinion for a new pharmaceutical form, solution for injection, associated with two new strengths (790 mg and 395 mg), along with a new route of administration, subcutaneous use. Keytruda is already authorized for the treatment of different types of cancer. For more information please consult the product for Keytruda on the EMA website.
Koselugo (Selumetinib): extension of indication for Koselugo to include the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in adult and paediatric patients with neurofibromatosis type 1 (NF1) aged 3 years and older. Previously Koselugo was only authorised for the treatment of paediatric patients. For more information please consult the product for Koselugo on the EMA website.
Tezspire (Tezepelumab): extension of indication for Tezspire to include the treatment as an 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. Tezspire is already authorised for the treatment of asthma in adults and adolescents from 12 years. For more information please consult the product for Tezspire on the EMA website.
Uplizna (Inebilizumab): extension of indication for Uplizma to include the treatment of adult patients with Immunoglobulin G4-related disease.
Uplizna is already authorised for the treatment of neuromyelitis optica spectrum disorders. There was a press release for the new indication. For more information please consult the product for Uplizna 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:
Attrogy: is indicated for the treatment of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy. EPAR Attrogy.
Aucatzyl: is indicated for the treatment of adult patients 26 years of age and above with relapsed or refractory (r/r) B cell precursor acute lymphoblastic leukaemia (B ALL). EPAR Aucatzyl.
Blenrep: is indicated in adults for the treatment of relapsed or refractory multiple myeloma:
- in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy; and
- in combination with pomalidomide and dexamethasone in patients who have received at least one prior therapy including lenalidomide.
Ezmekly: as monotherapy is indicated for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in paediatric and adult patients with neurofibromatosis type 1 (NF1) aged 2 years
and above. EPAR Ezmekly.
Itovebi: in combination with palbociclib and fulvestrant, is indicated for the treatment of adult patients with PIK3CA-mutated, oestrogen receptor (ER)-positive, HER2-negative, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine treatment (see section 5.1).
Patients previously treated with a CDK 4/6 inhibitor in the (neo)adjuvant setting should have had an interval of at least 12 months between termination of CDK 4/6 inhibitor treatment and the detection of recurrence. EPAR Itovebi.
Sephience: is indicated for the treatment of hyperphenylalaninaemia (HPA) in adult and paediatric patients with phenylketonuria (PKU). EPAR Sephience.
Vimkunya: is indicated for active immunisation for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 12 years and older. EPAR Vimkunya.
Previous CHMP Meeting Highlights can be accessed at: https://www.basg.gv.at/en/healthcare-professionals/chmp-highlights
