It's the first time that a drug meant to slow the disease’s progression, and not only target its symptoms, has been granted full regulatory approval.
, a brain protein that has long been believed by scientists to be one of the underlying causes of Alzheimer’s.of the new drug, disease progression was slowed by 27 percent over an 18-month period in 1,795 patients with mild cognitive impairment or early-stage Alzheimer’s. The medication also reduced sticky beta-amyloid plaques that can accumulate in the brains of people with the disease.
“[This] 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,” acting director of the Office of Neuroscience at the FDA’s Center for Drug Evaluation and Research Teresa Buracchio . “This confirmatory study verified that it is a safe and effective treatment for patients with Alzheimer’s disease.”, which primarily serves adults 65 and older. Until this approval, the federal insurance program has only covered the cost of Leqembi for patients in certain clinical trials.
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