Eisai, Biogen secure Leqembi FDA accelerated approval for Alzheimer’s disease

Eisai and Biogen have secured the approval of the US Food and Drug Administration (FDA) for their jointly developed Leqembi (lecanemab-irmb) under the accelerated approval pathway for the treatment of Alzheimer’s disease.

Leqembi is a 100 mg/mL injection for intravenous use, a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid beta (Aβ) for the treatment of Alzheimer’s disease.

Leqembi FDA accelerated approval is backed by the findings of a phase 2 clinical trial in which Alzheimer’s patients treated with the monoclonal antibody demonstrated a reduction in amyloid-beta plaque, a marker of Alzheimer’s disease.

Haruo Naito — Eisai CEO, commenting on Leqembi FDA accelerated approval, said: “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.

“Upon receiving this Accelerated Approval, we will focus on providing important information on proper usage of LEQEMBI to healthcare professionals.”

Eisai, Biogen secure Leqembi FDA accelerated approval for Alzheimer’s disease. Photo courtesy of Gerd Altmann from Pixabay .

Leqembi’s efficacy was demonstrated in a double-blind, placebo-controlled, parallel-group, dose-finding study of 856 patients with mild cognitive impairment or mild dementia stage of disease and confirmed the presence of amyloid beta pathology.

Commenting on Leqembi FDA accelerated approval, Christopher A Viehbacher — Biogen President and CEO, said: “The approval of LEQEMBI provides new hope to patients with Alzheimer’s disease.

“Eisai and Biogen have collaborated for nearly a decade to advance research to improve the lives of those suffering from Alzheimer’s, and we know that this commitment must and will continue in the fight against Alzheimer’s disease.”

Eisai has filed a supplemental biologics license application (sBLA) to the FDA for the conversion of the accelerated approval of Leqembi to a traditional approval based on the recently published data from Clarity AD, a confirmatory phase 3 clinical study.

Leqembi is expected to be available during or before the week of 23 January 2023.

Eisai with final decision-making authority will execute the Leqembi development and regulatory submissions worldwide while both Eisai and Biogen co-commercialize and co-promote the product.