The FDA on Monday approved an experimental drug that aims to slow the progression of Alzheimer's disease, despite the fact that a key FDA panel late last year said that questions remain about its effectiveness.
The FDA on Monday approved the use of aducanumab in patients in the early stages of Alzheimer's. Drugmakers Biogen and Eisai say the drug doesn't just address symptoms but actually slows the progression timeline of the disease.
Monday marks the first time that the FDA has approved a new Alzheimer's drug in nearly 20 years.
Aducanumab's approval faced several hurdles along the way.
NPR reports that the drug is designed to reduce the building up of amyloid plaques that grow in the brains of Alzheimer's patients. While studies have shown that the drug is effective in reducing plaque buildup, it's unclear if reducing that plaque can improve a person's cognitive function.
According to NPR, drugmakers ended two major studies of aducanumab when preliminary data suggested that the drug wasn't working. However, the companies decided to seek approval when a re-analysis of the data produced a more favorable result.
Ultimately, the FDA was presented with results from two major studies — one which showed the drug work, another which showed the drug didn't work.
Aducanumab's approval hit another snag in November when the FDA's Peripheral and Central Nervous System Drugs Advisory Committee was asked if it was reasonable to consider the data from one positive study for the drug's effectiveness. Ten of the panel members voted "no," and one was "uncertain" — none said yes.
While questions remain regarding the effectiveness of the drug, Alzheimer's patient groups will see the approval as a win.
"We believe strongly that if the FDA approves this treatment, it will be a new day for Alzheimer's," Harry Johns, the president and CEO of the Alzheimer's Association, told NPR. "This is not a cure. This is an incremental benefit, potentially, and that benefit can be very real in changing lives for so many."
