US Approves First New Alzheimer's Drug In Nearly 2 Decades

"Aduhelm is the first treatment directed at the underlying pathophysiology of Alzheimer's disease, the presence of amyloid beta plaques in the brain," said the FDA's Patrizia Cavazzoni.

The United States on Monday approved a drug called Aduhelm to treat patients with Alzheimer's, the first new medicine against the disease in almost two decades and the first to address cognitive decline linked to the condition. The decision was highly anticipated but also contentious, because an independent expert panel convened by the regulatory Food and Drug Administration last November found insufficient evidence of Aduhelm's benefit. "Aduhelm is the first treatment directed at the underlying pathophysiology of Alzheimer's disease, the presence of amyloid beta plaques in the brain," said the FDA's Patrizia Cavazzoni. Nevertheless, the decision falls under the FDA's "Accelerated Approval" pathway which it uses when it believes a medicine may provide meaningful benefit over existing treatments but there is still some uncertainty.