> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# 2nd Alzheimer’s Therapy Death Raises Questions: Journal
- URL: https://www.fdaweb.com/2nd-alzheimers-therapy-death-raises-questions-journal/
- Published: 2022-11-28T12:00:00.000Z
- Updated: 2026-09-14T18:07:34.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5153272

Questions are being raised about Eisai and Biogen’s lecanemab (BAN2401), an investigational anti-amyloid beta protofibril antibody for treating Alzheimer’s disease after a second death was reported in a patient taking the therapy. The journal *Science* is [reporting](https://www.science.org/content/article/second-death-linked-potential-antibody-treatment-alzheimer-s-disease?cookieSet=1&ref=fdaweb.com) that a 65-year-old woman who was receiving the promising experimental treatment recently died from a massive brain hemorrhage that some researchers link to the drug. The death, described in an unpublished clinical trial case report *Science* obtained, is the second thought to be associated with lecanemab. *STAT* recently [reported](https://www.statnews.com/2022/10/28/patient-death-lecanemab-alzheimers-trial/?utm%5Fsource=STAT+Newsletters&utm%5Fcampaign=77dcde7c5f-MR%5FCOPY%5F01&utm%E2%80%A6) that a man in his late 80s in lecanemab’s Phase 3 trial died of a brain hemorrhage linked to possible interaction between the antibody and Bristol Myers Squibb’s blood thinner Eliquis (apixaban).

Experts who reviewed the case report of the newly disclosed fatality told *Science* that it intensifies questions about lecanemab’s safety and how widely it should be prescribed if ultimately approved by FDA and other regulators. Eisai and Biogen have already submitted a BLA for accelerated approval of lecanemab, which FDA accepted in July ([see earlier story](https://www.fdaweb.com/eisai-biogen-claim-lecanemab-trial-success/)). The PDUFA action date on the BLA is 1/6/23.

Eisai declined to comment specifically on the deceased woman’s case, according to *Science*. “All the available safety information indicates that lecanemab therapy is not associated with an increased risk of death overall or from any specific cause,” the company said in a statement. Any safety information is reported to regulators and the trial’s principal investigators, Eisai said. “It can be difficult to determine what contributed to the death in any given patient, in particular when they are elderly, have multiple medical problems and may have recently received a concomitant treatment or intervention for an acute condition,” it added.