Biogen, Eisai finish filing with FDA for Alzheimer’s therapy lecanemab, seek priority review
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Biogen (NASDAQ:BIIB) and Eisai (OTCPK:ESALY) (OTCPK:ESALF) completed a rolling submission to the U.S. Food and Drug Administration (FDA) of their medicine lecanemab to treat Alzheimerâs disease (AD).
The companies said the biologics license application (BLA) was submitted under the FDA's accelerated approval pathway for lecanemab (BAN2401) to treat mild cognitive impairment (MCI) due to AD and mild AD (collectively known as early AD) with confirmed presence of amyloid pathology in the brain.
Japanese drugmaker Eisai has requested a priority review for the BLA.
The companies added that a confirmatory phase 3 trial, dubbed Clarity AD, conducted with 1,795 patients will report data in the Fall of 2022.
The companies said that the FDA agreed that the results of Clarity AD can serve as the confirmatory study to verify the clinical benefit of lecanemab.
Depending upon the results of the trial, Eisai may submit for full approval of lecanemab to the FDA during fiscal year 2022.
In March Stifel had downgraded Biogen shares over concerns of lecanemab's approval. Analyst Paul Matteis had noted that he saw ~30% chance of lecanemab winning an approval.
The companies had began the rolling submission in September 2021.
In March, the companies began filing application data for lecanemab to treat AD in Japan.
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