Physician Perspectives on FDA's Decision to Grant Accelerated Approval to Aducanumab for Alzheimer's Disease

Clin Pharmacol Ther. 2023 May 23. doi: 10.1002/cpt.2954. Online ahead of print.ABSTRACTIn June 2021, the Food and Drug Administration (FDA) granted accelerated approval to aducanumab, a monoclonal antibody indicated for the treatment of Alzheimer's Disease. The accelerated approval decision was controversial due to concerns about the use of an unvalidated surrogate measure, beta-amyloid, as the basis for approval and a lack of clinical outcome benefit. Between October 2021 and September 2022, we conducted a survey of a nationally representative group of internists, medical oncologists, and cardiologists to understand perspectives around aducanumab's approval and how this FDA decision may influence trust in other drugs approved through the accelerated approval pathway. Among 214 physician respondents familiar with the accelerated approval of aducanumab, 184 (86%) would not prescribe or recommend aducanumab. Further, 143 (67%) physicians reported losing trust in other drugs approved through the accelerated approval pathway due to FDA's decision with aducanumab. As a growing number of similar novel Alzheimer's Disease treatments are on the horizon, the first of which, lecanemab, already has received accelerated approval in January 2023, our survey findings provide insight into the impact of FDA's regulatory decisions on the perspectives and prescribing behavior of physicians concerning these novel drug treatments.PMID:37218658 | DOI:10.1002/cpt.2954
Source: Clinical Pharmacology and Therapeutics - Category: Drugs & Pharmacology Authors: Source Type: research