The EMA's CHMP recommended approval for two new medicines, Brinsupri for bronchiectasis and Wayrilz for immune thrombocytopenia, while advising against Rezurock for graft-versus-host disease. It also approved extensions for eight existing medicines, withdrew an application for hydrocortisone in preterm infants, confirmed the suspension of Oxbryta for sickle cell disease, and introduced a new administration route for Saphnelo. The meeting's agenda and minutes are forthcoming.
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 Several applications were withdrawn or received negative opinions, while some medicines underwent re-examination or extension of indications.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 European Medicines Agency's human medicines committee has recommended Leqembi (lecanemab) for treating early Alzheimer's disease in patients with one or no copies of the ApoE4 gene, due to a lower risk of amyloid-related imaging abnormalities (ARIA). This decision follows a re-examination of data showing Leqembi's benefits in slowing cognitive decline outweigh its risks in this restricted population. The recommendation includes safety measures like MRI monitoring and a controlled access programme to mitigate ARIA risks. The decision now awaits approval from the European Commission.
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 European Medicines Agency (EMA) has confirmed that atrial fibrillation (AF) will now be listed as a common side effect of medicinal products containing omega-3-acid ethyl esters. The EMA's safety committee found a dose-dependent increase in the risk of AF in patients with cardiovascular diseases or risk factors who were treated with omega-3-acid ethyl esters. The highest risk was observed at a dose of 4 g/d. Physicians, pharmacists, and patients will be informed of this risk through an update to the product characteristics and a notification to healthcare professionals.
The European Medicines Agency (EMA) is conducting a review of GLP-1 receptor agonists, including Ozempic, Saxenda, and Wegovy, due to reports of suicidal thoughts and self-injury. The review was triggered by the Icelandic medicines agency and is analyzing approximately 150 cases. It is unclear whether these cases are directly linked to the medications or other factors. The review is expected to conclude in November 2023. Patients and healthcare professionals are advised to use these medications according to approved guidelines and report any suspected side effects.
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.
