FDA Grants Accelerated Approval for Alzheimer’s Drug

Angie Szumlinski Announcements, News

On June 7, 2021 the FDA approved a new treatment for Alzheimer’s – Aduhelm (aducanumab). The approval was granted through the “accelerated approval pathway, which can be used for a drug for a serious or life-threatening illness that provides a meaningful therapeutic advantage over existing treatments”.

The director of the FDA’s Center for Drug Evaluation and Research, Patrizia Cavazzoni, M.D., explained that “currently available therapies only treat symptoms of the disease; this treatment option is the first therapy to target and affect the underlying disease process of Alzheimer’s. As we have learned from the fight against cancer, the accelerated approval pathway can bring therapies to patients faster while spurring more research and innovation.”