An insider's perspective on FDA approval of aducanumab.

ABSTRACT:

Introduction

Aducanumab was approved in 2021 by the US Food and Drug Administration (FDA) under the accelerated approval pathway. Since then, there have been many misconceptions about the approval decision despite multiple publications from the FDA to explain the rationale.

Methods

Even though the FDA's final decision was accelerated approval, the Office of Clinical Pharmacology recommended regular/full approval based on its own analyses. Exposure-response analyses were conducted to quantify the relationship between aducanumab longitudinal exposure and responses (standardized uptake values ratios for amyloid beta and various clinical endpoints) in all clinical trials. To explain the difference between aducanumab and other compounds with negative results in the past, publicly

SUBMITTER: Wang Y 

PROVIDER: S-EPMC10193636 | biostudies-literature | 2023 Apr-Jun

REPOSITORIES: biostudies-literature