The drug donanemab met all endpoints in the study that involved 1,736 participants and spanned 18 months, according to a May 3 news release from Eli Lilly. “Participants on donanemab had 40 percent less decline in ability to perform activities of daily living at 18 months,” the release said, “and participants on donanemab experienced a 39 percent lower risk of progressing to the next stage of disease compared to placebo.”
For adverse effects, MRIs detected swelling of the brain in 24 percent of treated patients, and 6.1 percent experienced this symptom. Among the donanemab group, 31.4 percent reported microhemorrhages or superficial siderosis, compared to 13.6 percent in the placebo group.
Two participants’ deaths are attributed to these amyloid-related imaging abnormalities, and a third death happened “after an incident of serious ARIA,” the drugmaker said.
A similar case happened with Eisai and Biogen’s recently approved Alzheimer’s drug, Leqembi (lecanemab), in which its phase 3 study recorded three patient deaths.
Eli Lilly said it would work toward FDA approval.
Becker’s 3rd Annual Fall Chief Pharmacy Officer Summit is the top tier event that the people leading the future of pharmacy convene. This 3-day event is built specifically for Chief Pharmacy Officers and senior pharmacy leaders. The sessions examine the workforce, financial and clinical priorities shaping pharmacy today. Becker’s is where candid discussions flourish and new ideas thrive. Becker's 3rd Annual Fall Chief Pharmacy Officer Summit
