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

This December 21, 2022 image provided by Eisai in January 2023 shows vials and packaging for their drug Leqembi. On Friday, January 6, 2023, U.S. health officials approved Leqembi, a new Alzheimer's drug that slightly slows down the brain-wasting disease. The Food and Drug Administration on Friday granted approval for patients in the early stages of Alzheimer's. (Eisai via AP)

The Food and Drug Administration has approved Alzheimer’s drug Leqembi (Image: AP)

The United States has become the first country to approve a controversial drug that slows the effects of Alzheimer’s disease.

The Food and Drug Administration (FDA) on Friday approved Leqembi, the brand name for lecanemab – a drug jointly developed by Japanese pharmaceutical company Eisai and American biotech giant Biogen.

Leqembi has been shown in clinical trials to slightly slow brain degeneration in patients with Alzheimer’s, the devastating neurodegenerative disease that causes most cases of dementia.

According to the Centers for Disease Control (CDC), an estimated 5.8 million Americans have Alzheimer’s.

A close-up of a human brain affected by Alzheimer’s disease on display at the Museum of Neuroanatomy at the University at Buffalo (Image: AP)

“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.

The CDC estimates that approximately 5.8 million Americans suffer from the effects of Alzheimer’s disease (Image: Getty Images)

“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.

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Justin Scacco

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