FDA to decide on full approval of Alzheimer's treatment Leqembi in early July
The drug, administered intravenously every two weeks, is expected to cost $26,500 a year
Biogen's new Alzheimer's drug could take 'some time' to reach Medicare market: Laura Chico
Wedbush Securities Senior Vice President of biotech equity research Laura Chico says questions remain about the benefits and risks of Biogen's experimental Alzheimer's drug.
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.
The Alzheimer's drug LEQEMBI is seen in this undated handout image obtained by Reuters on January 20, 2023. (Eisai/Handout via REUTERS / Reuters Photos)
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.
FILE PHOTO: A sign marks a Biogen facility in Cambridge, Massachusetts, U.S. January 26, 2017. (REUTERS/Brian Snyder / Reuters Photos)
| Ticker | Security | Last | Change | Change % |
|---|---|---|---|---|
| BIIB | BIOGEN INC. | 158.65 | -1.18 | -0.74% |
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.