Source: European Parliament
On 14 November 2024, the Committee for Medicinal Products for Human Use (CHMP), following a re-examination procedure, adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Leqembi, for the treatment of early Alzheimer’s disease in a restricted population of patients. It is for use in people who have only one or no copy of the ApoE4 gene and who have amyloid beta plaques in the brain.
Based on the CHMP opinion, the Commission prepared a draft decision, which was submitted for written consultation of the Member States in the Standing Committee on Medicinal Products for Human Use[1]. During this consultation, some Member States raised scientific questions, prompting the request for a plenary meeting, which was held on 24 January 2025. Following the meeting, the Commission consulted the CHMP on those scientific questions. The CHMP considered this request and concluded on 27 February 2025 that its November 2024 opinion recommending the marketing authorisation of Leqembi did not need to be updated.
Following the response from the CHMP, the Commission consulted the Member States on the draft Commission decision to authorise Leqembi. No qualified majority in favour of the decision was reached at the meetings of the Standing Committee on 21 March 2025[2] and of the Appeal Committee on 7 April 2025[3]. According to the procedures laid down in the legislation[4] and based on the EMA opinion, on 15 April 2025, the Commission adopted the decision to authorise Leqembi, which is published on the Union Register for Medicinal products[5].
- [1] https://health.ec.europa.eu/document/download/ba9e5b07-00d8-4e68-b539-0c9ac7c3c0f3_en?filename=2011_09_13_human.pdf.
- [2] https://ec.europa.eu/transparency/comitology-register/screen/documents/106397/1/consult?lang=en.
- [3] https://ec.europa.eu/transparency/comitology-register/screen/documents/106785/1/consult?lang=en.
- [4] Articles 5 and 6 of Regulation (EU) No 182/2011 https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32011R0182.
- [5] Union Register of medicinal products https://ec.europa.eu/health/documents/community-register/html/h1891.htm.