The first novel therapy for Alzheimer’s disease in almost two decades was approved Monday by the Food & Drug Administration.

Aducanumab (Aduhelm) is the first treatment directed at the underlying pathophysiology of Alzheimer’s disease — the presence of amyloid beta plaques in the brain. Clinical trials for the drug were the first to show a reduction in these plaques, which could reduce the clinical decline of individuals with this form of dementia.

Aducanumab was approved under the FDA’s accelerated approval pathway for serious or life-threatening illness. The pathway is intended to provide earlier access to potentially valuable therapies for patients with serious diseases “where there is an unmet need.” Based on the data, the FDA concluded that the benefits of aducanumab outweighed the risks.

Uncertainties about the drug’s clinical benefit remain, however. The drug has been at the center of intense debate among researchers, physicians, patients and advocates. The drug does not cure or reverse Alzheimer’s disease, and the price tag could up upward of $50,000 per year for patients.

The drug underwent two Phase 3 clinical trials, with one showing a reduction in clinical decline, whereas the second did not show the same results. In all studies, however, aducanumab “consistently and very convincingly” reduced plaque levels in the brain, which is expected to reduce clinical decline, according to the FDA.

The drug will undergo a Phase 4 confirmatory trial by Biogen to verify the anticipated clinical benefit. If those benefits are not verified, then the FDA could remove the drug from the market.

Patrizia Cavazzoni, M.D., director of the FDA Center for Drug Evaluation and Research, stated that the “need for treatments is urgent.” More than 6 million Americans are living with Alzheimer’s disease, the sixth-leading cause of death in the United States.

Approximately 42% of assisted living residents have dementia, according to the Centers for Disease Control and Prevention’s National Center for Health Statistics

Editor’s note: Read more on this news, including insights from ALG Senior Chief Medical Officer Kevin O’Neil, M.D., in an article from our McKnight’s Clinical Daily e-newsletter, a joint publication of McKnight’s Senior Living and McKnight’s Long-Term Care News.