On 22 March, Eisai announced that the Oral Explanation scheduled on 19 March at the Committee for Medicinal Products for Human Use (CHMP) for lecanemab, which is currently under review by the European Medicines Agency (EMA), did not take place. The company noted that this decision is entirely related to procedural reasons at the EMA and is not related to the marketing authorisation application (MAA) for lecanemab itself. It is a consequence of a 14 March legal ruling by the Court of Justice of the EU on the organisation of EMA’s Scientific Advisory Groups (SAGs) attendance.
The judgement has implications on EMA’s policy on the handling of competing interests of experts, in relation to SAG members. For this reason, the EMA has decided to annul advice it received from its neurology SAG meeting for lecanemab held on 11 March. The EMA will schedule a new SAG meeting for lecanemab. The timing for the new meeting has not been determined yet. The SAG is convened at the request of the CHMP of the EMA to provide independent advice on scientific or technical matters relating to products under evaluation by the CHMP, or on other scientific issues relevant to the work of the CHMP.
Lecanemab, which is marketed by Eisai and Biogen under the Leqembi® brand name, is an antibody that targets plaques of amyloid-beta proteins that accumulate in the brain during the development of Alzheimer’s disease (AD). Lecanemab was approved for the treatment of early AD by the US Food and Drug Administration in July 2023. Lecanemab is also approved in China and Japan. Approval was based on positive results from the CLARITY-AD clinical trial, which showed a 27% reduction in clinical decline for participants receiving lecanemab. Eisai announced the submission of a marketing authorisation application (MAA) for Lecanemab to the EMA on 11 January 2023.