FDA Converts Eisai Alzheimer’s Treatment to Traditional Approval

FDA announced on July 6, 2023, that it had converted its approval of Eisai’s Leqembi (lecanemab-irmb), indicated to treat patients with Alzheimer's Disease, from an accelerated approval to a traditional approval. Originally granted approval in January, the conversion followed a confirmatory trial which FDA determined verified clinical benefit. Lecanemab-irmb is an amyloid beta-directed therapy that is designed to reduce amyloid plaques that form in the brain, which is a defining pathophysiological feature of Alzheimer’s Disease.

The confirmatory study, Study 301, was a multicenter, randomized, double-blind, placebo-controlled, parallel-group study that enrolled 1,795 Alzheimer’s patients with mild cognitive impairment or mild dementia stage of disease and confirmed presence of amyloid beta pathology. According to the release, lecanemab-irmb demonstrated a statistically significant and clinically meaningful reduction of decline from baseline to 18 months on the primary endpoint, the Clinical Dementia Rating Scale Sum of Boxes score, relative to placebo. Statistically significant differences between treatment groups were also demonstrated on all secondary endpoints.

“Today’s action is the first verification that a drug targeting the underlying disease process of Alzheimer’s disease has shown clinical benefit in this devastating disease,” said Teresa Buracchio, acting director, Office of Neuroscience, Center for Drug Evaluation and Research, FDA, in the release. “This confirmatory study verified that it is a safe and effective treatment for patients with Alzheimer’s disease.”