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Diseases

European Parliament Approves Marketing Authorization for Leqembi for Early Alzheimer's Disease

Strategic Insights

— 2 min read

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for Leqembi, a medicinal product for the treatment of early Alzheimer's disease in a restricted population of patients. This decision was based on a re-examination procedure, following which the CHMP concluded that its November 2024 opinion recommending the marketing authorisation of Leqembi did not need to be updated. The European Commission consulted the Member States on the draft Commission decision to authorise Leqembi, but no qualified majority in favour of the decision was reached. Despite this, the Commission adopted the decision to authorise Leqembi on 15 April 2025, which is published on the Union Register for Medicinal products.

Key Takeaways:

  • The CHMP adopted a positive opinion for the marketing authorization of Leqembi for the treatment of early Alzheimer's disease in a restricted population of patients.
  • The CHMP re-examined the opinion and concluded that it did not need to be updated.
  • The European Commission consulted the Member States on the draft Commission decision to authorise Leqembi, but no qualified majority in favour of the decision was reached.
  • The Commission adopted the decision to authorise Leqembi on 15 April 2025, despite the lack of a qualified majority.
  • The authorization of Leqembi is published on the Union Register for Medicinal products.
  • The decision is based on the EMA opinion and follows the procedures laid down in the legislation.

Statistics:

  • 21 March 2025: The Standing Committee met and no qualified majority in favour of the decision was reached.
  • 7 April 2025: The Appeal Committee met and no qualified majority in favour of the decision was reached.
  • 14 November 2024: The CHMP adopted a positive opinion recommending the marketing authorisation for Leqembi.
  • 27 February 2025: The CHMP concluded that its November 2024 opinion did not need to be updated.
  • 15 April 2025: The Commission adopted the decision to authorise Leqembi.

Sources:

  • 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.
  • https://ec.europa.eu/transparency/comitology-register/screen/documents/106397/1/consult?lang=en (Accessed on 13 May 2025)
  • https://ec.europa.eu/transparency/comitology-register/screen/documents/106785/1/consult?lang=en (Accessed on 13 May 2025)
  • Articles 5 and 6 of Regulation (EU) No 182/2011 (Accessed on 13 May 2025)
  • https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32011R0182 (Accessed on 13 May 2025)
  • Union Register of medicinal products (Accessed on 13 May 2025)

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