EMA CHMP recommends approval for six new medicines

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued positive opinions for the approval of six new medicines and the extension of therapeutic indications for five existing drugs.

Among the new approvals is Rasonque (daraxonrasib) by Revolution Medicines Netherlands B.V. for treating metastatic pancreatic adenocarcinoma in adults. Eli Lilly Nederland B.V. received a favorable opinion for Foundayo (orforglipron), an oral GLP-1 receptor agonist for weight management and type 2 diabetes treatment. Additionally, Ascendis Pharma Growth Disorders A/S received approval for Yuviwel (navepegritide) to treat achondroplasia in children.

Other approved products include biosimilars Fovlussea (ranibizumab) from Accord Healthcare and Neuzafy (filgrastim) from Curateq Biologics, as well as the hybrid medicine Kizfizo (temozolomide) from Orphelia Pharma. The committee also recommended indication extensions for several authorized medicines, including AstraZeneca’s H5N1 pandemic influenza vaccine and Novo Nordisk’s Kyinsu (insulin icodec semaglutide).