Eisai submits MAA for lecanemab in Europe

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Eisai has submitted a Marketing Authorisation Application (MAA) for lecanemab, for early Alzheimer’s (mild cognitive impairment due to Alzheimer’s (AD) and mild AD dementia) patients in Europe.

This application was submitted to the European Medicines Agency (EMA). The submission comes just after lecanemab’s recent accelerated approval by the US Food and Drug Administration (FDA). Approved as a treatment for early AD, the treatment is sold in the US under the brand name Leqembi.

FDA grants accelerated approval for Leqembi

Clarity AD study for Alzheimer’s

The Marketing Authorisation Application is based on results of the Phase III Clarity AD study and the Phase IIb clinical study. Data indicated that lecanemab treatment showed a reduction of clinical decline in early AD. This is subject to a validation to determine whether the EMA accepts the application for review.

The Phase III study findings suggested that the drug could slow progression of the disease by 2.5-3.1 years, helping patients to have slower cognitive decline and thus stay in earlier stages of the disease for a longer period.

Clinical trial results of the Clarity AD study were presented at the 2022 Clinical Trials on Alzheimer’s Disease (CTAD) conference, and simultaneously published in the New England Journal of Medicine in November 2022.

The trial met its primary endpoint (CDR-SB1: Clinical Dementia Rating-Sum of Boxes) and all key secondary endpoints with highly statistically significant results.

The most common adverse events (AEs), >10 percent in the lecanemab group were infusion reactions, ARIA-H (combined cerebral microhaemorrhages, cerebral microhaemorrhages, and superficial siderosis), ARIA-E (edema/effusion), headache, and fall.

Other regulatory submissions for lecanemab

Eisai submitted a Supplemental Biologics License Application (sBLA) to the FDA for approval under the traditional pathway on the same day.

In December 2022, Eisai initiated submission of data for a Biologics License Application (BLA) to the National Medical Products Administration (NMPA) of China. In Japan, Eisai plans to submit a MAA by the end of March 31, 2023.