Green light for new medicines at September 2025 meeting

The European Medicines Agency (EMA) has recommended 14 new medicines for approval at its September meeting. The key Committee on Human Medicinal Products (CHMP) reviews safety and efficacy data before publishing its opinion, which is forwarded to the European Commission for final approval. It has recommended 85 products in 2025.

New medicines given the green light in September include:

• Enflonsia (clesrovimab), for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants.
• Imaavy (nipocalimab), for the treatment of generalised myasthenia gravis, a disease that leads to muscle weakness and tiredness.
• 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.
• Lynkuet (elinzanetant) 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.