FDA grants approval to first Alzheimer's drug Leqembi

The US Food and Drug Administration (FDA) has granted traditional approval to the Alzheimer's drug lecanemab, known by the brand name Leqembi, following an earlier accelerated approval this year.

Teresa Buracchio, acting director of the Office of Neuroscience in the FDA's Center for Drug Evaluation and Research, said in a news statement, "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."

Developed by drugmakers Eisai and Biogen, Leqembi is the first medication proven to slow the progression of Alzheimer's disease, including declines in memory and cognitive function, by targeting the disease's underlying biology.

Christopher A. Viehbacher, president and CEO of Biogen, hailed the approval as a breakthrough, remarking, "Today marks a breakthrough in the treatment of Alzheimer's disease, and we are proud to be at the forefront of ushering in a new era of advances for a disease that was previously considered untreatable."

Viehbacher added that Biogen and Eisai are committed to working together to make Leqembi accessible to eligible patients as soon as possible. The FDA's initial approval in January was based on a mid-stage study involving 800 individuals exhibiting early signs of Alzheimer's, who were still able to live independently or with minimal assistance. Eisai subsequently published the results of a larger study involving 1,800 patients, which the FDA evaluated during the full approval process.

The larger study tracked patients' cognitive functions using an 18-point scale measuring memory and other cognitive abilities. The results showed a difference of less than half a point after 18 months, sparking a debate over whether this qualifies as a meaningful improvement.

According to the latest news release, the decision to grant full approval was unanimous, with all committee members agreeing that the study results confirmed the drug's benefits. Buracchio emphasised in her statement, "This confirmatory study verified that it is a safe and effective treatment for patients with Alzheimer's disease."

The FDA defines Alzheimer's disease as an irreversible and progressive brain disorder that affects over 6.5 million Americans, gradually impairing memory, thinking skills, and the ability to perform simple tasks.

The approval of Leqembi follows the controversy surrounding the FDA's handling of a previous Alzheimer's drug, Aduhelm, also developed by Biogen and Eisai. Aduhelm received approval in 2021 despite warnings from independent medical advisers regarding its effectiveness and significant risks. The FDA subsequently updated its labeling to restrict the drug's use.