The US Food and Drug Administration (FDA) has approved the anti-amyloid agent aducanumab (Eduhelm, Biogen/Christian) for the treatment of Alzheimer’s disease (AD), approving a recommendation by its own advisory panel Disregard the recommended not to give the drug.
Aducanumab was approved using the accelerated approval route, which can be used to fast-track a drug that offers a meaningful therapeutic advantage over existing treatments for a serious or life-threatening disease. However, under this route, the FDA requires Biogen to conduct a new randomized, controlled clinical trial to verify the clinical benefit of the drug. In an FDA release, the agency said it has the option of withdrawing its approval if the drug fails to show clinical benefit in this trial.
The approval of aducanumab is the first new treatment approved for AD since 2003 and the first to target beta-amyloid, a hallmark of the disease. In November, the Peripheral and Central Nervous System Drugs Advisory Committee voted eight to one against approving the drug because, based on clinical trial results, the evidence for efficacy was not strong enough. Two other members said they were unsure of the issue of efficacy.
The FDA noted that today’s approval was based on three separate double-blind, randomized, dose-based studies representing a total of 3382 patients with AD. Those receiving the active drug, the FDA said, had a significant dose- and time-dependent reduction of beta-amyloid plaques, while the control group had no reduction in amyloid.
AD is a devastating disease that can have a profound impact on the lives of people diagnosed with the disease as well as their loved ones, said Patrizia Cavazzoni, MD, of the FDA’s Center for Drug Evaluation and Research. “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,” she said.
Source: MedScape