Following the US approval of the drug on January 6 under the commercial name Leqembi, Tokyo-headquartered Eisai (which takes the lead on the collaboration with Biogen on the drug) has submitted marketing authorization applications to the European Medicines Agency (announced on Jan 10) and Japan’s Pharmaceuticals and Medical Devices Agency (announced Jan 15).
In Japan, the company has used a prior assessment consultation system with the PMDA, which can be used to shorten the review period for lecanemab. It has not, however, given an expected timescale for the process.
In Europe, the process will be particularly closely watched with Eisai hoping to succeed where Biogen's anti-amyloid Alzheimer's drug Aduhelm failed (in December 2021, the agency knocked down the Aduhelm application citing an insufficient link between amyloid beta reduction and clinical improvement and concerns over incidence of amyloid related imaging abnormalities (ARIA)).
Elsewhere, Eisai initiated submission of data for a BLA to the National Medical Products Administration (NMPA) of China back in December.
Lecanemab is an anti-amyloid beta (Aβ) protofibril antibody for the treatment of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD dementia (collectively known as early AD) with confirmed presence of amyloid pathology in the brain.
The applications to Europe's EMA and Japan's PMDA are based on the results of the Phase III Clarity AD study and Phase IIb clinical study.
In the US, the drug received approval from the US Food and Drug Administration (FDA) this month under the accelerated approval pathway; with Eisai having now submitted a supplemental Biologics License Application for the traditional approval pathway as well.
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.
In the Clarity AD study, lecanemab treatment resulted in 'highly statistically significant results, reducing clinical decline on the global cognitive and functional scale as the primary endpoint (CDR-SB2: Clinical Dementia Rating-Sum of Boxes) as early as six months, and over time across all time points'.
All key secondary endpoints also showed highly statistically significant results. Especially, treatment with lecanemab showed a statistically significant reduction in amyloid plaque burden at all timepoints starting at 3 months in the amyloid PET study and statistically significantly slowed decline of activities of daily living on ADCS MCI-ADL3.
The most common adverse events (>10%) in the lecanemab group were infusion reactions, ARIA-H (combined cerebral microhemorrhages, cerebral macrohemorrhages, and superficial siderosis), ARIA-E (edema/effusion), headache, and fall.
