Bringing accelerated approval to the brain

FDA’s approval of aducanumab from Biogen for Alzheimer’s disease marks the first use of the accelerated approval pathway for the disease and, according to agency officials, sets a precedent for accelerated approvals of other neurodegenerative disorders. Controversy over the approval, especially over the strength of the correlation between β-amyloid clearance and clinical benefit, as well as concerns about FDA’s ability to withdraw drugs if clinical benefit has not been demonstrated, has provoked calls for regulatory or legislative changes that could redefine accelerated approval.

Though initially created to speed development of HIV/AIDS treatments by allowing for approvals based on surrogate endpoints, FDA and drug sponsors have adapted the accelerated approval pathway for cancer and other diseases...