Leqembi is a humanised immunoglobulin gamma 1 (IgG1) monoclonal antibody, indicated as a 100mg/mL intravenous injection, for the treatment of Alzheimer's disease in patients with mild cognitive impairment or mild dementia stage of disease

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Leqembi is a humanised IgG1 monoclonal antibody. (Credit: Milad Fakurian on Unsplash)

Eisai and Biogen have received the US Food and Drug Administration (FDA) approval for their Alzheimer’s disease (AD) medication Leqembi (lecanemab-irmb), under the accelerated approval pathway.

Leqembi is a humanised immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble and insoluble forms of amyloid beta (Aβ).

The drug is indicated as a 100mg/mL intravenous injection, for the treatment of AD in patients with mild cognitive impairment or dementia, and confirmed Aβ pathology.

The FDA approval is supported by Phase 2 clinical trial data, which showed that Leqembi reduced the accumulation of Aβ plaque in the brain, a characteristic of AD.

Biogen president and chief executive officer Christopher A Viehbacher said: “Patients at an early stage of the disease and their caregivers can now consider a new treatment option with their doctors.

“This approval is also a recognition of the many scientists and doctors who have, over many years, patiently and persistently worked to find a treatment for this highly complex 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.”

In a separate development, Eisai has submitted a Supplemental Biologics License Application (sBLA) to the FDA, seeking regulatory approval under the traditional pathway.

The sBLA is based on recently published data from the Phase 3 Clarity AD clinical trial.

In March last year, Eisai and Biogen amended their existing collaboration on Alzheimer’s drug Aduhelm and extended the supply agreement tenure for lecanemab to 10 years.

Under the extended collaboration, Eisai is responsible for the global development and regulatory submissions for Leqembi and holds the final decision-making authority.

The sBLA is subject to the US health regulator accepting the regulatory application for review.

Eisai chief executive officer Haruo Naito said: “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.

“Eisai will also engage with various payers to provide access to Leqembi, offer a patient support program, and will do its utmost to complete submission for traditional approval as soon as possible to serve more people living with early Alzheimer’s disease.”