FierceBiotech: Eisai, Lilly Alzheimer’s trials withheld brain injury risk: NYT

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Eisai, Lilly Alzheimer’s trials withheld brain injury risk: NYT

Eisai, Eli Lilly didn't disclose heightened brain injury risk to Alzheimer's trial patients: NYT


Eisai, Eli Lilly didn’t disclose heightened brain injury risk to Alzheimer’s trial patients: NYT

A new bombshell has been dropped in the scandal-plagued world of Alzheimer’s disease drug development. According to a New York Times reportthis week, Eisai and Eli Lilly, in the clinical trials for their respective Alzheimer’s drugs Leqembi and Kisunla, genetically tested participants to identify those with a higher risk of developing the disease, but didn’t disclose the results to patients—even though that genetic predisposition was also linked to a higher risk of brain injuries as a side effect of both drugs.

Between the two companies, more than 560 people joined the trials without being told they had a heightened risk of dangerous side effects such as brain bleeding or swelling, the Times reported, including 274 in the Eisai trial and 289 in Lilly’s.

Both companies had participants sign consent forms that included secrecy provisions around the results of the genetic risk testing, according to the Times.

Two high-risk participants in the Eisai trial died, and more than 100 others experienced brain injuries, most of them “mild and asymptomatic,” but some “serious and life-threatening,” per the report. In the Lilly study, researchers reportedly identified “dozens” of participants who experienced brain bleeding classified as “severe.”