Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 October 2024

Ten new medicines recommended for approval The committee recommended granting a marketing authorisation for Alhemo (concizumab), a medicine for routine prophylaxis of bleeding in patients with haemophilia A or B with inhibitors, two types of a rare inherited bleeding disorder. The CHMP adopted positive opinions for two vaccines intended for active immunisation against influenza: Fluad (surface antigen, inactivated, adjuvanted), intended for adults 50 years of age and older, and Flucelvax (surface antigen, inactivated, prepared in cell cultures), for adults and children from two years of age. Korjuny (catumaxomab) received a positive opinion from the CHMP for the intraperitoneal treatment of malignant ascites, a build-up of fluid containing cancer cells in the abdomen of cancer patients. The CHMP gave a positive opinion for Siiltibcy (rd ESAT-6 / r CFP-10), for the diagnosis of infection with Mycobacterium tuberculosis. According to the World Health Organization, 10.6 million new tuberculosis cases were estimated and 1.6 million people died from the disease in 2021. Wainzua* (eplontersen) received a positive opinion for the treatment of adults with hereditary transthyretin-mediated amyloidosis, a rare disease caused by variants in the transthyretin gene that results in high mortality, and stage 1 or 2 polyneuropathy, the simultaneous malfunction of many peripheral nerves throughout the body. The committee adopted positive opinions for Absimky (ustekinumab) and Imuldosa...