US HHS to review FDA's accelerated approval pathway

The US Food and Drug Administration’s recent approval of Aduhelm (aducanumab) to treat patients with Alzheimer's disease using the accelerated approval pathway has been questioned and now this is to be investigated by the Office of the Inspector General at the Department of Health and Human Services.

The accelerated approval pathway allows the FDA to approve drugs that treat serious conditions and that fill an unmet medical need based on a surrogate endpoint, which is a marker that is thought to predict a clinical benefit.

The FDA's approval of Biogen (Nasdaq: BIIB) and Eisai’s (TYO: 4523) Aduhelm raised concerns due to alleged scientific disputes within the FDA, the advisory committee's vote against approval, allegations of an inappropriately close relationship between the FDA and the industry, and the FDA's use of the accelerated approval pathway.