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Mayo Clinic doctor reacts to FDA approval of new Alzheimer’s drug

ROCHESTER, Minn. (FOX 47) -- Some exciting news broke Monday for patients dealing with Alzheimer's. The Food and Drug Administration (FDA) approved a new drug to help slow the progression of the disease.

The last time the FDA approved a drug for Alzheimer's was in 2003, and that was just to help manage symptoms.

"This is the first drug that been approved by the FDA as a disease modifying therapy," said Dr. Ronald Petersen, Mayo Clinic's Alzheimer's Disease Research Center Director and Neurologist. "And by that, I mean that it actually acts on the underlying causes of the disease One of the proteins that's involved with Alzheimer's disease, amyloid, is removed from the brain by this drug."

The new drug Aducanumab would be administered through an IV once a month. Patients with mild stages of Alzheimer's would be prime candidates.

"The data indicates that the drug may in fact slow the progression of the disease in this range, and that's important for those individuals," Petersen said.

Petersen also said patients who end up using this drug will need to be monitored.

"The drug might cause some leakage in the blood vessels, such that fluid or blood could leak into the brain," Petersen said. "And as such, patients who receive the drug will probably need to be monitored with serial MRI scans to detect that possible side-effect."

And the FDA's decision to approve this drug was a controversial one.

"The FDA approved it on their accelerated pathway program," Petersen said. "Which means that they approved it on the basis of the drugs action on the biomarkers, that is it's ability to remove amyloid from the brain. But they require the sponsor to provide additional efficacy data, so they require the sponsor to preform another trial to show that there is actually a clinical benefit from the drug."

Dr. Petersen said the FDA will require a phase four study to document the drugs effectiveness and side-effects. If it fails, the drug could be pulled from the market.

Sarah Gannon

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