Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 October 2025
The European Medicines Agency's (EMA) human medicines committee, CHMP, reviewed several medicines in October 2025. Two new medicines received positive recommendations for approval. Brinsupri, containing brensocatib, was recommended for treating a specific condition. Wayrilz, with rilzabrutinib, also received a positive recommendation for its designated therapeutic use. Rezurock, containing belumosudil, received a negative recommendation. Austedo, with deutetrabenazine, underwent re-examination resulting in a positive outcome. The CHMP also recommended extensions of therapeutic indications for several existing medicines. These include Breyanzi, Cejemly, Gazyvaro, Libtayo, Paxlovid, Pyrukynd, Tremfya, and Scemblix, with decisions pending. A marketing authorization application for Hydrocortisone Aguettant was withdrawn. The EMA also confirmed the suspension of Oxbryta for sickle cell disease, reflecting a public health recommendation.