FDA Approves New Alzheimer’s Drug
On June 7, 2021, the U.S. Food and Drug Administration (FDA) approved Aduhelm (aducanumab), a new Alzheimer’s drug for the treatment of the disease. Aduhelm was approved using the “accelerated approval pathway,” which can be used for a drug for a serious or life-threatening illness that provides a therapeutic advantage over existing treatment. According to the FDA, “accelerated approval can be based on the drug’s effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients, with a required post-approval trial to verify that the drug provides the expected clinical benefit.” Was the approval of [...]