FDA officials will decide on July 6 whether to grant full approval to the new Alzheimer’s treatment Leqembi, Japanese drugmaker Eisai and its U.S. partner Biogen said on Monday.
The drug, known chemically as lecanemab, is administered intravenously twice a month and has been shown to reduce brain amyloid plaque, a marker of Alzheimer’s.
The FDA granted the drug accelerated approval for patients with mild or early cases of dementia in January based off a Phase 2 study.
An advisory committee to the FDA will meet to discuss results from a Phase 3 study involving 1,795 participants last year that found a 27% reduction in cognitive and functional decline over an 18-month period compared to a placebo.
“Today’s announcement gives patients and their families hope that lecanemab, if approved, can potentially slow the progression of Alzheimer’s disease, and provide a clinically meaningful impact on cognition and function,” Biogen CEO Michel Vounatsos said in a statement after the Phase 3 study results were released.
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The exact date for that advisory committee hearing has not been announced.
Without full approval, access to the drug is still extremely limited for the more than six million Americans who suffer from the disease. Leqembi is expected to cost about $26,500 a year.
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Shares of Biogen stock are up about 33.13% over the past year.