WASHINGTON (thehill): The Food and Drug Administration (FDA) on Monday granted approval for the first new Alzheimer’s treatment since 2003, greenlighting Biogen’s drug aducanumab.
In a statement, the FDA said it decided to use an “accelerated approval” pathway to make drugs and therapies available to patients enduring “serious diseases where there is an unmet need” and “an expectation of clinical benefit.”
“In determining that the application met the requirements for Accelerated Approval, the Agency concluded that the benefits of Aduhelm for patients with Alzheimer’s disease outweighed the risks of the therapy,” the FDA added.
