Eisai : FDA Accepts BLA And Grants Priority Review For Lecanemab To Treat Early Alzheimer's Disease

BioArctic AB's partner Eisai said that the U.S. Food and Drug Administration has accepted the Biologics License Application or BLA under the accelerated approval pathway for lecanemab, an investigational anti-amyloid beta (Aß) protofibril antibody for the treatment of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD, with confirmed presence of amyloid pathology in the brain.

Eisai's application has been granted Priority Review with a Prescription Drug User Fee Act (PDUFA) action date on January 6, 2023.

BioArctic stated that the acceptance of the BLA by the FDA entitles BioArctic to a milestone payment of 15 million euros from Eisai.

BioArctic noted that Eisai will submit for traditional approval of lecanemab to the FDA before the end of the first quarter 2023.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Home improvement retailer Lowe's Cos., Inc. reported Wednesday an increase in earnings per share for the second quarter that also topped analysts' estimates. However, quarterly sales edged down and missed expectations. The company also reaffirmed its guidance range for the full-year 2022. While reporting financial results for the second quarter on Wednesday, off-price retailer TJX Companies, Inc. (TJX) provided financial outlook for the third and the fourth quarters as well as slashed its guidance for the full-year 2023. For the third quarter, the company projects earnings in a range... American Airlines announced an agreement to purchase up to 20 Overture supersonic jets, the world's fastest airliner, from transportation start-up Boom Supersonic, with an option for an additional 40. Overture, which is expected to carry passengers at twice the speed of the fastest commercial aircraft available at present, would provide an important new speed advantage to American's fleet.
Follow RTT