Lecanemab granted Fast Track designation by the FDA
Stockholm, December 24, 2021 - BioArctic AB’s (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that lecanemab, an investigational anti-amyloid beta (Aβ) protofibril antibody for the treatment of early Alzheimer’s disease (AD), was granted Fast Track designation by the U.S. Food and Drug Administration (FDA). The FDA granted Breakthrough Therapy designation for lecanemab in June of 2021. Breakthrough Therapy designation and Fast Track designation are two FDA programs that are intended to facilitate and expedite development of new drugs to address unmet medical need in the
