Eisai and Biogen Announces Acceptance of New Drug Submission (NDS) for Lecanemab
Tuesday, May 16, 2023
Eisai and Biogen announced that Health Canada has accepted a New Drug Submission (NDS) for lecanemab, an investigational anti-amyloid beta (Aβ) protofibril* antibody, for the treatment of early Alzheimer’s disease (mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD dementia) with confirmed amyloid pathology in the brain.
Lecanemab was approved under the accelerated approval pathway in the U.S. and was launched in the U.S. on January 18, 2023. The accelerated approval is based on Phase II data that demonstrated that lecanemab reduced the accumulation of Aβ plaque in the brain, a defining feature of AD, and its continued approval may be contingent upon verification of lecanemab’s clinical benefit in a confirmatory trial.
The NDS is based on the results of the Phase III Clarity AD study and Phase IIb clinical study (Study 201), which demonstrated the lecanemab treatment showed a reduction of clinical decline in early AD. Lecanemab selectively binds and eliminates soluble, toxic Aβ aggregates (protofibrils) that contributes to the neurotoxicity in AD. As such, lecanemab has the potential to have an effect on disease pathology and to slow down the progression of the disease.
