FDA grants fast track designation to Alzheimer’s antibody therapy

The FDA has granted fast track designation for lecanemab, an investigational antiamyloid beta protofibril antibody used for treatment of patients in the early stages of Alzheimer’s disease.

The FDA previously granted breakthrough therapy designation for lecanemab (BAN2401; Eisai/Biogen) in June.

In September, the multinational biotech firm opted for a rolling submission of a biologics license application (BLA) for the drug under the accelerated approval pathway.

The BLA was based on the results of a phase 2b study in which results demonstrated a high degree of amyloid beta plaque reduction, as well as consistent diminishing of decline across several clinical endpoints among patients in the early stages of AD who were confirmed to show amyloid pathology.

Correlation between the degree of amyloid beta plaque reduction and its subsequent effect on clinical endpoints in the study further supported amyloid beta as a surrogate endpoint that is likely to produce positive therapeutic results.

The Lecanemab Clarity AD phase 3 clinical study is underway, with a total enrollment of 1,795 patients. Upon completion, the FDA has agreed that results of the trial will stand as final verification of the drug’s clinical benefit.

Another phase 3 clinical study involving lecanemab, AHEAD 3-45, aims to evaluate the benefit of treatment in participants who display preclinical AD and elevated amyloid, as well as in those with early preclinical AD and intermediate amyloid.

Eisai has also commenced a phase 1 study for lecanemab, in which the drug is administered by injection under the skin.