Biogen/Eisai Alzheimer’s Drug Wins Full FDA Approval

The FDA has granted full approval to Leqembi, the first and only approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline in adults with Alzheimer’s disease (AD). According to Eisai, which developed the drug with Biogen, Leqembi could generate $7 billion in annual sales globally by 2030. Eisai serves as the lead of LEQEMBI development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.

Leqembi demonstrated clinically meaningful slowing of cognitive and functional decline in a patient group representative of U.S. Medicare beneficiaries, which included a mix of racial and ethnic groups, patients with common comorbid conditions, concomitant medications and patients with mild cognitive impairment (MCI) due to AD. Treatment with Leqembi should be initiated in patients with MCI or mild dementia stage of disease (collectively referred to as early AD), the population in which treatment was initiated in clinical trials.

“Today, the FDA approved Leqembi under the traditional approval pathway, making Leqembi the first and only approved anti-amyloid Alzheimer’s disease treatment shown to reduce the rate of disease progression and to slow cognitive impairment in the early and mild dementia stages of the disease…,” said Eisai CEO Haruo Naito. “Today marks a breakthrough in the treatment of Alzheimer’s disease, and we are proud to be at the forefront of ushering in a new era of advances for a disease that was previously considered untreatable…,” said Biogen President and CEO Christopher Viehbacher.

Leqembi is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril*) and insoluble forms of amyloid beta (Aβ). Leqembi targets and clears the most neurotoxic form of Aβ that continuously accumulates as well as removes the existing plaques to treat this progressive, chronic disease. In January, 2023, Leqembi was approved by the FDA under the accelerated approval pathway. In June the FDA’s Peripheral and Central Nervous System Drugs (PCNS) advisory committee voted unanimously that the data from Eisai’s clinical trial confirmed the clinical benefit and overall risk-benefit of Leqembi. (Source: Biogen Website, 06 July, 2023)