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

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval for ten new medicines. These include Alhemo (concizumab) for bleeding prevention, Fluad and Flucelvax influenza vaccines, Korjuny (catumaxomab) for cancer treatment, Siiltibcy (rdESAT-6/rCFP-10) for tuberculosis, and Wainzua (eplontersen) for a rare genetic disorder. The CHMP also recommended approval for two biosimilars, Absimky and Imuldosa, both containing ustekinumab for psoriasis and psoriatic arthritis. A hybrid medicine, Buprenorphine Neuraxpharm (buprenorphine) for opioid dependence, and a generic medicine, Eltrombopag Viatris (eltrombopag) for thrombocytopenia, were also recommended. Furthermore, extensions of therapeutic indications were recommended for several existing medicines, including Cerdelga, Hepcludex, Kevzara, Kisqali, Tevimbra, and Yselty. Two initial marketing authorisation applications for Apremilast Viatris and Epixram were withdrawn, and re-examinations were conducted for Masitinib and Translarna.