Benzinga -
- A 65-year-old woman with early Alzheimer's disease receiving Biogen Inc (NASDAQ:BIIB)'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.