Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 September 2024

EMA’s human medicines committee elects new Chair The Committee for Human Medicinal Products (CHMP) elected Bruno Sepodes as its new chair. Professor Sepodes starts his three-year mandate on 21 September and succeeds Dr Harald Enzmann as chair, who completed the maximum two three-year terms allowed for CHMP chairs. More information is available in EMA’s news announcement. Eight new medicines recommended for approval The CHMP recommended granting a marketing authorisation for Elahere* (mirvetuximab soravtansine), a medicine intended for the treatment of adults with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. The committee recommended granting a marketing authorisation for Hetronifly* (serplulimab), for the treatment of extensive-stage small cell lung cancer. Hympavzi* (marstacimab), received a positive opinion for the treatment of bleeding episodes in patients aged 12 years and older with severe haemophilia A or B, two types of a rare inherited bleeding disorder. The CHMP adopted a positive opinion for Penbraya (meningococcal groups A, C, W, Y conjugate and group B vaccine (recombinant, adsorbed)), a vaccine indicated for immunisation against invasive disease caused by Neisseria meningitidis, a Gram-negative bacterium, often referred to as meningococcus, that colonizes the upper respiratory tract, which, in some individuals, can cause serious, life-threatening invasive meningococcal disease. Theralugand (lutetium (177 lu) chloride), a...