FDA grants accelerated approval for early Alzheimer’s drug

The U.S. Food and Drug Administration has approved Leqembi (lecanemab-irmb) for the treatment of Alzheimer’s disease, according to a press release.

Approval was granted via the Accelerated Approval pathway based on results from the phase 3 randomized, controlled clinical trial which confirmed the clinical benefit of lecanemab.

In the double-blind, placebo-controlled, parallel-group, dose-finding study, 856 patients with Alzheimer’s disease with mild cognitive impairment or mild dementia stage of disease and confirmed presence of amyloid beta pathology were randomized to receive lecanemab or placebo. A significant dose- and time-dependent reduction of amyloid beta plaque was reported in patients receiving lecanemab. Those who received the 10 milligram/kilogram every 2 weeks had a statistically significant reduction in brain amyloid plaque from baseline to Week 79 compared to the placebo arm.

“Alzheimer’s disease immeasurably incapacitates the lives of those who suffer from it and has devastating effects on their loved ones,” said Billy Dunn, MD, director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research in a press release. “This treatment option is the latest therapy to target and affect the underlying disease process of Alzheimer’s, instead of only treating the symptoms of the disease.”

Read the full press release here.