Here is our regular summary of content of relevance to neruology from the April issue of the European Medicines Agency’s (EMA) newsletter.
- Approval of Leqembi (lecanemab) Following a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) in November 2024, the European Commission granted marketing authorisation to Leqembi (lecanemab), a treatment for early Alzheimer’s disease. Click here for more details.
- First AI-Based Tool Qualified for Regulatory Use The CHMP issued its first qualification opinion on AIM-NASH, an artificial intelligence (AI) tool designed to assist pathologists in evaluating liver biopsy scans for metabolic dysfunction-associated steatohepatitis (MASH) in clinical trials. Click here for more details.
- Consultation on Biosimilar Medicines Development The EMA released a draft reflection paper open for public consultation until the end of September, exploring improvements in the development and evaluation of biosimilar medicines. The proposed approach aims to potentially reduce the amount of clinical data required, enhancing patient access in the EU. Click here for more details.
- CTIS Designated as WHO Primary Registry The Clinical Trials Information System (CTIS) has been designated as a primary registry by the World Health Organization (WHO), meeting specific criteria for content, technical, and administrative aspects. This designation promotes transparency and trust in clinical research. Click here for more details.
- Review of Mysimba (naltrexone/bupropion) The CHMP concluded that the benefits of Mysimba, used for managing obesity or overweight, continue to outweigh its risks. However, the company is required to provide additional data from an ongoing study concerning long-term cardiovascular effects in patients treated for over a year. New risk minimisation measures have been implemented for long-term use. Click here for more details.
- Consultations on Package leaflet key information The EMA is conducting a consultation on the potential addition of a “key information section” to the package leaflet. The consultation runs until the end of August. Click here for more details.
- Survey for healthcare professionals involved in academic medicine development open until 5 May EMA is inviting views from academic and not-for-profit developers to understand better their needs for scientific and regulatory support. Click here for more details.
- Negative CHMP opinions on Kinsula (donanemab) The EMA has recommended the refusal of marketing authorisation for Kisunla (donanemab), a medicine intended for the treatment of early Alzheimer’s disease.
- Withdrawal of application for extension of indication of Amyvid (florbetapir (18F)) Eli Lilly Nederland B.V. withdrew its application for the use of Amyvid (florbetapir (18F)), a radiotracer used in PET imaging, in adults to monitor their response to treatments aimed at reducing beta-amyloid plaques associated with Alzheimer’s disease.
