FDA Grants Accelerated Approval for Alzheimer’s Disease Treatment
January 23, 2023   

The U.S. Food and Drug Administration (FDA) recently approved leucanemab (Lequembi), via the Accelerated Approval pathway for the treatment of Alzheimer’s disease. This is the second of a novel category of medications approved for AD, that targets the AD specific pathology of amyloid beta plaques. The approval was based on the results of a Phase 3 randomized, controlled clinical trial where researchers evaluated the efficacy of the agent in this double-blind, placebo-controlled, parallel-group, dose-finding study of 856 patients with Alzheimer’s disease. Those patients with mild cognitive impairment or mild dementia stage of disease and confirmed presence of amyloid pathology underwent treatment. They received the approved dose of leucanema; 10 milligram/kilogram every two weeks, and reportedly had statistically significant reduction in brain amyloid plaque from baseline to Week 79, compared to the placebo arm, which had no reduction of amyloid beta plaque. These results support the accelerated approval of leucanemab, due to the observed reduction of amyloid beta plaque, a marker of Alzheimer’s disease. Prescribing information includes a warning for amyloid-related imaging abnormalities (ARIA), which are known to occur with antibodies of this class. The most common side effects of leucanemab were infusion-related reactions, headaches, and ARIA.

>>  FDA Press Release

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