EMA recommends approval of 14 new medicines

EMA has recommended the approval of 14 new medicines. They are expected to be reviewed and approved by the European Commission. These include:

• Enflonsia (clesrovimab), intended for the prevention of respiratory syncytial virus (RSV) in newborns and infants
• Imaavy (nipocalimab) for the treatment of generalized myasthenia gravis
• Kyinsu (insulin icodec/semaglutide) for the management of type 2 diabetes and
• Lynkuet (elinzanetant), indicated for the treatment of moderate to severe vasomotor symptoms associated with menopause.

The Committee also approved nine biosimilar medicines. Seven of them are based on denosumab – Acvybra, Denosumab Intas, Kefdensis, and Ponlimsi. These are indicated for the treatment of osteoporosis and bone loss. Additionally, Degevma, Xbonzy, and Zvogra were approved. They are intended for the prevention of skeletal-related events in adults and the treatment of giant cell tumor of bone. Approval was also granted to Gobivaz (golimumab) for the treatment of various autoimmune diseases, including rheumatoid and psoriatic arthritis, axial spondyloarthritis, and ulcerative colitis, and Usgena (ustekinumab), indicated for Crohn’s disease, plaque psoriasis (including pediatric cases), psoriatic arthritis, and ulcerative colitis.

The CHMP also recommended a positive opinion for one generic medicine – Rivaroxaban Koanaa (rivaroxaban), intended for the prevention and treatment of venous thromboembolism, deep vein thrombosis, pulmonary embolism, as well as for the prevention of stroke and systemic embolism in patients with various risk factors.

In addition to the new medications, the committee recommended expanding the therapeutic indications for six already approved medicines. These include Uplizna (inebilizumab), which can now also be used for the treatment of IgG4-related autoimmune disease; Bimervax – with an updated composition against the new SARS-CoV-2 variant (LP.8.1); Dupixent; Keytruda; Koselugo; and Tezspire. Keytruda will also be available in a new pharmaceutical form for subcutaneous administration.

Furthermore, changes were adopted for the existing indications of the oncology drugs Lunsumio and Lutathera, as well as the antiretroviral drug Norvir (ritonavir), which will provide healthcare professionals with more up-to-date and detailed information when treating patients.