CLEVELAND — 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.
"We’re optimistic and thrilled they approved it,” said Colleetta DeChant. She made a career of caring for people as a nurse; now, she cares for her husband Ron, who is battle Alzheimer's disease. "Let's just stop it where it is, if we could stop it where it is it would be tremendous."
About 3,000 people around the globe took part in the clinical trial; Ron was part of that trial at the Cleveland Clinic.
“It’s a turning point in our field no matter how you look at it," DeChant said.
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.
"One of the hallmarks of Alzheimer's is the clumping of the amyloid protein in the brain," said Dr. Babak Tousi with the Cleveland Clinic trials program. "This medication binds itself to the amyloid plaque in the toxic form and helps the immune system identify and get rid of it from the system."
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."
For the DeChants, Monday was a day of hope and promise. Ron, a retired pharmacist, knows the power pharmaceuticals can hold.
"I’m very happy this is going foward," he said. "Hopefully if it can’t help me, it can help others. There are a lot of people in the same boat."
Scripps National correspondent Alex Hilder contributed to this report. View his original story here.
