FDA approves Eisai-Biogen’s lecanemab for Alzheimer’s disease

The FDA has approved Eisai and Biogen’s experimental antibody treatment lecanemab (also known as Leqembi) for the treatment of mild cognitive impairment or mild dementia in patients with Alzheimer’s disease (AD).

The drug was approved under the FDA’s Accelerated Approval Pathway and takes the form of a 100mg/mL intravenous injection. The approval follows positive data obtained in a phase 2 clinical trial during which lecanemab reduced plaque accumulation on the brain, which appears to be a defining feature of AD.

It is estimated that within three years, lecanemab could treat around 100,000 patients, with this figure increasing over the mid-to-long term. Eisai have already submitted a supplemental Biologics License Application (sBLA) to the FDA in order to obtain traditional approval from the FDA, as well as using data from the phase 3 confirmatory Clarity AD trial to support this application. Results from the Clarity AD trial showed lecanemab meeting the primary endpoint and all critical secondary endpoints.

Haruo Naito, Eisai’s CEO, commented: “The FDA’s approval of Leqembi under the Accelerated Approval pathway is an important milestone in Eisai’s four decades of research in Alzheimer’s disease and reflects our continued commitment to alleviating the burden of Alzheimer’s disease for patients and their families. […] Eisai has made great efforts to understand the reality of the challenges and concerns facing patients and their families who are living in the various stages of Alzheimer’s disease, and we are incredibly pleased to offer Leqembi as a new treatment option to help with the tremendous unmet needs of this community.”

Betsy Goodfellow