“Eisai takes seriously its responsibility to protect the privacy of patients who contribute to medical science by participating in our studies,” a spokesperson told Becker’s.
It can be difficult to “determine the specific cause of death in any given patient, in particular when they are elderly and have multiple medical problems,” the spokesperson said. “The well-being of the patients enrolled in our clinical studies is always Eisai’s top priority.”
The study participant experienced swelling and bleeding in the brain, according to an Oct. 28 report in The Wall Street Journal. Eisai’s spokesperson said the tested drug, lecanemab, is not associated with a risk of death, and after sharing information with regulators, will present the trial’s data Nov. 29.
In a global study of nearly 2,000 people, Eisai tested lecanemab against a placebo and reported a promising 27 percent slower cognitive decline.
Other anti-amyloid drugs like lecanemab have also been associated with side effects of swelling and bleeding in the brain, according to the Journal. In the phase 3 trial, about 12 percent of the study participants who took lecanemab developed swelling and bleeding in the brain, Biogen and Eisai said in a Sept. 27 news release.
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