KANSAS CITY, Mo. — The U.S. Food and Drug Administration has granted full approval of an Alzheimer’s drug that many hope will help slow the disease.
The government agency had signed off on the drug Leqembi despite ongoing research surrounding its safety, cost and accessibility.
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“Today’s action is the first verification that a drug targeting the underlying disease process of Alzheimers 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 Thursday in a release from the agency. “This confirmatory study verified that it is a safe and effective treatment for patients with Alzheimer’s disease.
The FDA estimates that more than 6.5 million Americans suffer from the progressive brain disorder.
A June 9 vote by the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee unanimously concluded the drug provided “clinical benefit” for the indicated use.
The drug comes from a partnership of two drug companies, Japan-based Eisai and U.S.-based Biogen.
Additional information about the drug and side effects is available on the FDA’s website.
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