The EMA's CHMP recommended approval for 13 new medicines in July 2025, including treatments for rare diseases, cancer, HIV prevention, and postpartum depression, along with biosimilars, generics, and updates on vaccine compositions. Several applications were withdrawn or received negative opinions, while some medicines underwent re-examination or extension of indications. The meeting also included safety reviews and updates on ongoing public health procedures.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended 14 new medicines for approval and seven for extended therapeutic indications during its May 2024 meeting. Highlights include Adzynma for congenital thrombotic thrombocytopenic purpura, Akantior for acanthamoeba keratitis, and Ixchiq, the first EU vaccine for Chikungunya. Additionally, the CHMP confirmed the refusal of marketing authorisation for Nezglyal and restarted the evaluation for Translarna's renewal.
The Committee for Medicinal Products for Human Use (CHMP) recommended three new medicines for approval, including Exblifep for urinary tract infections, Ryzneuta for neutropenia, and Niapelf for schizophrenia, while refusing marketing authorizations for Nezglyal and Syfovre. The committee also recommended extensions of therapeutic indication for four medicines and confirmed its original recommendation to not renew the conditional marketing authorization for Translarna. Additionally, the CHMP endorsed measures to minimize risks for medicines containing pseudoephedrine and will re-examine its opinion on generic medicines following a request.
The Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of seven new medicines, including Casgevy, the first medicine using CRISPR/Cas9 gene-editing technology, for the treatment of transfusion dependent beta-thalassemia and severe sickle cell disease. Other recommended medicines include Skyclarys for Friedreich's ataxia, Velsipity for ulcerative colitis, and four generic medicines. The CHMP also confirmed the non-renewal of a conditional marketing authorization for Blenrep. Additionally, extensions of therapeutic indications were recommended for four medicines, and positive opinions were adopted for two medicines intended for use outside the EU. The CHMP has also recommended the suspension of marketing authorizations for certain generic medicines tested by Synapse Labs Pvt. Ltd due to irregularities in study data.
Amylyx Pharmaceuticals faces a second round of questions from the Committee for Medicinal Products for Human Use (CHMP) in its bid to have AMX0035 approved as a treatment for amyotrophic lateral sclerosis (ALS) in Europe. The company will respond to the questions and expects an opinion from the committee by mid-2023. The EMA will consider that opinion in its decision on AMX0035’s potential approval.
