Biogen, Eisai's Alzheimer's therapy lecanemab gets FDA priority review
Naeblys

The U.S. Food and Drug Administration (FDA) granted priority review to Biogen (NASDAQ:BIIB) and Eisai's (OTCPK:ESALY) (OTCPK:ESALF) lecanemab to treat mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD (collectively early AD)
Eisai's biologics license application (BLA) was accepted by the FDA under the accelerated approval pathway.
The FDA is expected to make a decision by Jan. 6, 2023. Under a priority review the FDA's goal is to take action on an application within 6 months, compared to 10 months under standard review.
The companies said the FDA agreed that main goal data from a phase 3 trial called Clarity AD, which is expected in fall 2022 â serve as the confirmatory study to verify the clinical benefit of lecanemab.
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 added that depending upon Clarity AD results, Eisai will file for traditional approval of lecanemab with the FDA during the Japanese drugmaker's fiscal year 2022, which ends on March 31, 2023.
Lecanemab approval could be a boost for the companies, considering their prior AD therapy Aduhelm (aducanumab) had its own woes.
Eisai said it has begun submitting application data for lecanemab with the Japanese drug regulator and expects to file for approval in fiscal year 2022. Eisai also expects to seek EU approval in fiscal year 2022 based on results of the study.
Eisai is heading lecanemab's development and regulatory submissions globally, while both Eisai and Biogen will co-commercialize and co-promote the product with Eisai having final decision-making authority.