The Food and Drug Administration on Friday approved Leqembi, a drug that may modestly slow the cognitive declines associated with Alzheimer’s disease.
The drug, developed by Japan’s Eisai and Biogen in the United States, has been shown in clinical trials to slow thinking and memory loss for Alzheimer’s patients with early or mild forms of the disease, according to The Associated Press. The delay is likely to only amount to a few months, the AP reported, though experts said it “could still meaningfully improve people’s lives.”
“This drug is not a cure. It doesn’t stop people from getting worse, but it does measurably slow the progression of the disease,” Dr. Joy Snider, a neurologist at Washington University in St. Louis, told the AP. “That might mean someone could have an extra six months to a year of being able to drive.”
The drug was approved through the FDA’s accelerated approval pathway, which allows the agency to green light medicines aimed at treating serious conditions when there is an unmet medical need for the treatment and the drug is shown to likely benefit patients.
“This treatment option is the latest therapy to target and affect the underlying disease process of Alzheimer’s, instead of only treating the symptoms of the disease,” Billy Dunn, director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, said Friday in a statement. He noted that the disease “immeasurably incapacitates the lives of those who suffer from it and has devastating effects on their loved ones.”
More than 6.5 million Americans have Alzheimer’s disease, the most common type of dementia, according to the FDA. It affects parts of the brain that control thought, memory and language, typically presenting with mild memory loss and potentially progressing to loss of the ability to perform daily activities like having a conversation.
Scientists don’t fully understand what causes Alzheimer’s disease. Changes associated with the disease can begin years before the first symptoms appear, according to the Centers for Disease Control and Prevention.
“The approval of LEQEMBI provides new hope to patients with Alzheimer’s disease,” Biogen president and CEO Christopher Viehbacher said in a statement. He added that Biogen would focus next on making the drug available to patients “as soon as possible.”
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