US approves first new drug for Alzheimer's disease in nearly 20 years

The US Food and Drug Administration (FDA) on Monday approved the use of the experimental drug Aducanumab (Aduhelm) manufactured by Biogen for the treatment of the early phases of Alzheimer's disease in a breakthrough decision after nearly two decades. The newly approved drug provides a meaningful therapeutic benefit over existing treatments as the medicine has shown to have an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients, the FDA said in a release.

It however added, that there remains some uncertainty about the drug’s clinical benefit. Aduhelm is the first treatment directed at the underlying pathophysiology of Alzheimer’s disease, and its significant dose over a longer period of time has shown the reduction of amyloid-beta plaque in the brains. 

The progressive brain disorder in the likeness of dementia, Alzheimer's disease (AD) gradually destroys memory and cognitive skills. There's no cure for Alzheimer’s. The US FDA had earlier issued a number of warnings and advisory letters to at least 17 companies for selling illegal products that claimed to prevent, treat or cure Alzheimer's disease and the serious conditions related to the disease. However, in its latest findings, the FDA found that the clinical trials for Aduhelm were the first to show that a reduction in the brain amyloid plaques—a hallmark finding for the patients with Alzheimer’s. 

“We are well-aware of the attention surrounding this approval. We understand that Aduhelm has garnered the attention of the press, the Alzheimer’s patient community, our elected officials, and other interested stakeholders. With a treatment for a serious, life-threatening disease in the balance, it makes sense that so many people were following the outcome of this review,” US FDA said in a press release.

FDA's accelerated approval’

The persistent use of the drug has also shown the clinical decline of this devastating form of dementia, the US FDA stated. Alzheimer’s disease accounts for 60 to 80 percent of dementia cases and most people are diagnosed after the age of 65. The FDA hasn’t approved any drug against Alzheimer's disease since 2003. The FDA used the ‘accelerated approval’ process to allow the drug usage against the serious or life-threatening form of Alzheimer’s illness. Although it agreed that the trial results were highly complex and left residual uncertainties regarding a clinical benefit. 

“At the end of the day, we followed our usual course of action when making regulatory decisions in situations where the data are not straightforward,” the committee said, adding that it solicited the inputs and feedback from the Peripheral and Central Nervous System Drugs Advisory Committee. The Peripheral and Central Nervous System Drugs Advisory Committee, which convened in November 2020, reviewed the clinical trial data and discussed the evidence supporting the Aduhelm application.