Alzheimer’s Drug Gets FDA Approval

By on July 7, 2023

FDA facebook post announcing approval of drug

From CNN, by Meg Tirrell, Nadia Kounang and Tami Luhby

(CNN )— The US Food and Drug Administration on Thursday [July 6, 2023] granted traditional full approval to the Alzheimer’s drug Leqembi, the first medicine proven to slow the course of the memory-robbing disease.

The Centers for Medicare and Medicaid Services said Thursday that it will now expand coverage of the drug, broadening access for up to an estimated million people with early forms of the disease.

“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,” Teresa Buracchio, acting director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, said in the announcement. “This confirmatory study verified that it is a safe and effective treatment for patients with Alzheimer’s disease.”

Leqembi, from drugmakers Eisai and Biogen, received accelerated approval in January based on evidence that it clears amyloid plaque buildups in the brain that are associated with Alzheimer’s disease. But because of an earlier coverage decision by CMS, which provides insurance coverage for many elderly people with Alzheimer’s through Medicare, the drug hasn’t been widely used. It costs $26,500 annually before insurance coverage.

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