10 Jul 2023 • The US Food and Drug Administration on Thursday granted traditional full approval to the Alzheimer’s drug Leqembi(lecanemab), the first medicine proven to slow the course of the disease. Leqembi is the first amyloid beta-directed antibody to be converted from an accelerated approval to a traditional approval for the treatment of Alzheimer’s disease. The drug works by reducing amyloid plaques that form in the brain, a defining pathophysiological feature of the disease.

Efficacy of Leqembi was evaluated using the results of Study 301 (CLARITY AD), a Phase 3 randomized, controlled clinical trial.

• Study 301 was a multicenter, randomized, double-blind, placebo-controlled, parallel-group study that enrolled 1,795 patients with Alzheimer’s disease.
• Patients were randomized in a 1:1 ratio to receive placebo or Leqembi at a dose of 10 milligrams (mg)/kilograms (kg), once every two weeks
• Leqembi delayed cognitive decline by 5.3 months compared to placebo after 18 months of treatment, at a time when such delays are most valuable to the individual

Leqembi should be initiated in patients with mild cognitive impairment or mild dementia stage of Alzheimer’s disease. The most common side effects of Leqembi were headache, infusion-related reactions and amyloid-related imaging abnormalities (ARIA), a side effect known to occur with the class of antibodies targeting amyloid.

In January, the drug received what's known as accelerated approval from the FDA, based on its ability to remove the substance beta-amyloid from the brains of people in the early stages of Alzheimer's. Full or traditional approval reflects the FDA's assessment that Leqembi also helps preserve memory and thinking, according to a report by NPR.

Source: FDA | Read full story