FDA approves new Alzheimer鈥檚 drug
The Food and Drug Administration today Biogen鈥檚 Aduhelm to treat Alzheimer鈥檚 disease, the first new treatment approved for the disease since 2003. The drug was approved using the accelerated approval pathway, which is typically used when a drug for a serious or life-threatening illness is found to have a meaningful therapeutic advantage over existing treatments.
Aduhelm represents a first-of-its-kind treatment approved for Alzheimer鈥檚 disease in that it is the first therapy that targets the disease鈥檚 fundamental pathophysiology. As part of the accelerated approval provisions, which enables Alzheimer鈥檚 patients鈥 earlier access to treatment, FDA is requiring Biogen to conduct a new randomized, controlled clinical trial to verify the drug鈥檚 clinical benefit. In the event the trial fails to verify the drug鈥檚 clinical benefit, FDA may withdraw its approval.