The US is the first country to approve a controversial Alzheimer’s drug

“Alzheimer’s disease immeasurably impacts the lives of those who suffer from it and has a devastating impact on their loved ones,” said Dr. Billy Dunn, the director of the Office of Neuroscience at the FDA’s Center for Drug Evaluation and Research.

“This treatment option is the latest therapy that targets and affects the underlying disease process of Alzheimer’s rather than just treating the symptoms of the disease,” Dunn said.

The FDA advised that the drug be used in patients with “mild cognitive impairment or mild dementia” rather than those with more severe symptoms.

However, Leqembi is far from a cure for Alzheimer’s, some neurologists say.

“It doesn’t stop people from getting worse, but it measurably slows the progression of the disease,” said neurologist Dr. Joy Snider of Washington University in St. Louis. “That could mean that someone can drive six months to a year longer.”

Aduhelm, another Alzheimer’s drug developed by Eisai and Biogen, has come under fire after a Senate investigation found its approval process was “riddled with irregularities.”

Leqembi also carries the potential for some serious side effects. In studies, around 13% of patients taking Leqembi had brain swelling. Another 17% suffered from cerebral hemorrhage, which can cause dizziness and blurred vision.

Several other patients died while taking the drug, including two who were also taking blood-thinning medication. The FDA has advised doctors not to prescribe Leqembi to patients taking blood thinners.

Leqembi was approved through the FDA’s accelerated approval route, which allows drug manufacturers to obtain approval quickly. An approval decision was originally planned for March 2023.