Lecanemab (Leqembi) Receives Full FDA Approval as First Alzheimer’s Treatment in Two Decades

On July 6, the FDA's official website showed that lecanemab (brand name: Leqembi), jointly developed by Eisai/Biogen, has successfully converted its accelerated approval for the treatment of Alzheimer's disease (AD) into full approval. This also means that lecanemab has become the first new AD therapy to receive full FDA approval in 20 years.

Lecanemab is an anti-amyloid beta (Aβ) monoclonal antibody that selectively neutralizes and eliminates soluble and toxic Aβ aggregates, which cause Alzheimer's disease neuropathology. Therefore, lecanemab may positively impact the AD pathological process and slow disease progression. Eisai and Biogen jointly oversee the development and commercialization of this product, with Eisai retaining final decision-making authority.

On January 6, based on the results of the Phase IIb proof-of-concept clinical trial (BAN2401-G000-201), the FDA approved the marketing application for lecanemab for the treatment of AD under the accelerated approval pathway. However, lecanemab treatment can only be administered to AD patients with mild cognitive impairment or mild dementia and confirmed presence of Aβ pathology.

On the same day that lecanemab received accelerated approval, Eisai submitted an sBLA to the FDA seeking full approval for lecanemab. This application is based on the positive results of the confirmatory Phase III Clarity AD study, which met its primary endpoint and all key secondary endpoints, with results showing high statistical significance.

On June 10, at the FDA Peripheral and Central Nervous System Drugs Advisory Committee, the expert panel unanimously supported lecanemab's full approval based on the positive results of the Phase III CLARITY AD study, with a vote of 6 to 0.

Currently, the pricing for lecanemab is $26,500 per year. The U.S. Centers for Medicare & Medicaid Services (CMS) has previously indicated that it may consider expanding coverage when lecanemab receives full approval.

It is worth mentioning that the marketing application of lecanemab in China was accepted by the CDE in December 2022.

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