Eisai says CHMP oral explanation for lecanemab rescheduled

Biogen (BIIB) noted that Eisai (ESAIY) announced an update on the regulatory review process of lecanemab by the European Medicines Agency, or EMA. Eisai announced that the Oral Explanation scheduled for March 19 at the Committee for Medicinal Products for Human Use, or CHMP, for lecanemab, which is currently under review by the European Medicines Agency, or EMA, did not take place due to procedural reasons at the EMA. On March 14, the Court of Justice of the European Union ruled on the organisation of EMA’s Scientific Advisory Groups, or SAGs, attendance. “The judgment 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 the advice obtained at the SAG-N – Scientific Advisory Group on Neurology – meeting for lecanemab held on March 11, 2024. The EMA will reconvene another SAG-N meeting for lecanemab. The timing for the new meeting has not been determined yet. This decision is entirely related to procedural reasons at the EMA and is not related to the marketing authorization application – MAA – for lecanemab itself. Eisai will continue to collaborate with the EMA towards the deliberations of lecanemab. Eisai serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority,” Eisai stated.