Open Questions On Safety Lingers After Eisai-Biogen's Detailed Lecanemab Data For Alzheimer's

Open Questions On Safety Lingers After Eisai-Biogen's Detailed Lecanemab Data For Alzheimer's
  • According to detailed dataEisai Limited ESALY and Biogen Inc's BIIB closely watched trial of an experimental Alzheimer's drug slowed cognitive decline but may carry a risk of side effects for certain patients.
  • Lecanemab was associated with a type of brain swelling in 12.6% of trial patients, a side effect previously seen with similar drugs. 
  • 17.3% of patients had microhemorrhages in the brain— a symptom linked to two recent deaths of people receiving lecanemab in a follow-on study.
  • Treatment with lecanemab reduced clinical decline on the global cognitive and functional scale by 27% at 18 months, relative to the placebo, the trial's primary endpoint.
  • Two deaths— both from brain hemorrhages— have been reported among participants in a trial extension - a 65-year-old woman who received a type of medicine known as tissue plasminogen activator to clear blood clots after a stroke and an 87-year-old who was on the blood thinner Eliquis.
  • Eisai said the two deaths "cannot be attributed to lecanemab."
  • The FDA is slated to decide by January 6 whether to approve lecanemab under its accelerated review program.
  • Price Action: BIIB shares are up 6.05% at $308.97 on the last check Wednesday.

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