NEW HOPE: Biogen shares soar on Alzheimer's drug developments
"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 statement. "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.
Though some participants in the study experienced brain swelling or brain bleeding, Biogen said that the incidence was "within expectations."Eisai, which is serving as the lead of lecanemab development and regulatory submissions globally, will discuss the findings with regulatory authorities in the U.S., Japan and Europe.
In March, the Japanese pharmaceutical giant submitted application data, with the exception of the latest study, to Japan's Pharmaceuticals and Medical Devices Agency with the goal of obtaining early approval for lecanemab. In July, the U.S. Food and Drug Administration accepted Eisai’s Biologics License Application under an accelerated approval pathway and granted priority review.
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