Biogen's Potential Early Alzheimer's Treatment Sees Second Death Linked To It, Shares Fall
A 65-year-old woman with early Alzheimer's disease receiving Biogen Inc's (NASDAQ: BIIB) antibody lecanemab treatment to slow the cognitive decline recently died from a massive brain hemorrhage that some researchers link to the drug.
Clinical trial death is the second thought associated with the lecanemab.
STAT recently reported that an 80-year-old man in lecanemab's phase 3 trial died of a brain hemorrhage linked to the possible interaction between the experimental antibody and the blood thinner Eliquis (apixaban).
The newly disclosed fatality intensifies questions about its safety and how widely lecanemab should be prescribed if ultimately approved.
This week, Biogen's partner Eisai Limited (OTC: ESALY) is scheduled to provide the first detailed account of the phase 3 Clarity AD trial, which enrolled about 1800 patients with signs of early Alzheimer's disease.
Two months ago, Biogen and Eisai announced surprising positive results from a late-stage study of their Alzheimer's treatment candidate.
Treatment with lecanemab reduced clinical decline on the global cognitive and functional scale by 27% at 18 months, relative to the placebo, which is the primary endpoint. That was statistically significant in the analysis of the intent-to-treat population.
If approved, lecanemab would be the second anti-amyloid drug to reach the clinic. Aducanumab, a recently approved drug for Alzheimer's disease, also from Eisai and Biogen, is now on the market as Aduhelm.
Price Action: BIIB shares are down 4.22% at $292.26 during the premarket session on the last check Monday.
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