In a global study of 1,795 people with mild cognitive impairment or mild Alzheimer’s disease, Biogen and Tokyo-based pharmaceutical company Eisai tested their Alzheimer’s drug candidate, lecanemab, against a placebo. After 18 months, the study participants who received 10 milligrams of lecanemab biweekly had statistically significant results.
The results could help fast track the drug toward full approval in Japan, Europe and the U.S. as it awaits the FDA’s OK for an accelerated approval pathway and priority review.
“Today’s announcement gives patients and their families hope that lecanemab, if approved, can potentially slow the progression of Alzheimer’s disease and provide a clinically meaningful impact on cognition and function,” Biogen CEO Michel Vounatsos said in a Sept. 27 news release. “Importantly, the study shows that removal of aggregated amyloid beta in the brain is associated with a slowing of disease in patients at the early stage of the disease.”
Biogen and Eisai said they will publish the clinical study in November and seek approval for lecanemab by March 2023.
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