Promising Alzheimer’s drug back on track for approval

U.S. & World

(CNN) – A drug that helps manage Alzheimer’s disease is one step closer to getting approval from the federal government, and researchers are calling this historic.

“Overnight, this drug went from off the shelf, done, to now being the next potential drug approved,” said Dr. Marwan Sabbagh, director of the Lou Ruvo Center at The Cleveland Clinic.

During the initial analysis, the anti-amyloid agent aducanumab didn’t show enough promise for the FDA to pursue it, according to Sabbagh.

But a deeper dive into the data from a test group at the Ruvo Center showed that it clearly removed plaque or amyloids from the brains of Alzheimer’s patients.

“These are before, these are after. This is the placebo group. Red is all the amyloid in the brain. This is the highest dose. This is before and after. This is a year later. This is a brain full of amyloid, all red. And this is a brain empty of amyloid after a year,” Sabbagh said while showing a reporter some photos.

Now, based on its ability to slow down the effects of Alzheimer’s, some are calling aducanumab a history-making drug.

It’s maker, Biogen, is set to take it to the FDA for approval in a few months, meaning it could be on the market as early as next year.

Sabbagh makes it clear that this is not a cure for Alzheimer’s, but it would be used instead for management.

“It’s important because if we could avoid all those complications because they’re staying well, or just mildly impaired, they’re not getting worse, the downstream benefits are gigantic,” Sabbagh said.

This includes benefits for the families of patients who might never need to put a loved one in a nursing home.

“Best case scenario is they have mild Alzheimer’s dementia. We refill their meds every six months, and 7 years later, they’re still very mild, or even slightly better, and they’re not worse. They’re still in their home, they’re still somewhat semi-independent,” Sabbagh said.

Sabbagh warns that the drug might not be cheap if it’s approved by the FDA. He’s also unsure if the medicine will be covered by insurance plans.

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