Dissecting FDA’s aducanumab decision: a BioCentury podcast
BioCentury’s editors weigh the pros and cons of the accelerated approval
BioCentury’s editors weigh the pros and cons of the accelerated approval.
Has FDA made the correct decision in approving Biogen’s aducanumab for Alzheimer’s disease? On the latest BioCentury This Week podcast, BioCentury’s editors break down the impact of the agency granting accelerated approval to the anti-β-amyloid drug, including the new surrogate endpoint for the decision, the potential for eroded trust in FDA, and what’s next in the pipeline. They also preview BioCentury’s upcoming China Healthcare Summit.
Executive Editor Selina Koch expresses surprise that FDA chose to approve the drug via the accelerated approval pathway.
“I had assumed, and apparently incorrectly, that in order to use a biomarker as a surrogate endpoint, FDA would want to have seen in the past a demonstration that that biomarker and clinical benefit correlate with each other. And that has not been demonstrated for amyloid,” Koch says.
“This is a very marginal therapy. The amount of benefit, if you believe there is benefit, is right up on the threshold of clinical meaningfulness,” she says. “Patients will get worse over time. There’s no way to know if they would have been even worse without it, there just won’t be.”
As a result, Koch argues, use of the drug may diminish over time because it is a “burdensome” therapy that is “not cheap.”