A priority for a new drug for Alzheimer's disease

Eisai and Biogen announced that the US Food and Drug Administration (FDA) will process as a matter of priority an application for the marketing of lecanemab, an anti-beta-amyloid antibody. The Agency has indicated 6 January next year as the target date for the publication of the decision.

The drug manufacturers are applying for approval for two indications: treatment of mild cognitive impairment due to Alzheimer's disease and treatment of mild Alzheimer's disease with confirmed brain amyloid pathology.

The rationale for the application is mainly based on clinical, biomarker and safety data from study 201. This was a Phase IIb study involving 856 patients with mild cognitive impairment due to Alzheimer's disease or mild dementia due to Alzheimer's disease. Participants were randomized to receive lekanemab or placebo. Although the study failed to meet its primary endpoint, twice-weekly drug anemab reduced the amount of amyloid in the brain by 0.306 SUVr units after 18 months (from a baseline mean of 1.37), and more than 80% of patients were amyloid negative on the imaging tests.

A Phase III study (Clarity AD) is currently underway to find out if druganemab can safely and effectively slow cognitive decline. The results are expected in September this year.

Source: FirstWorldPharma