By Ted Scouten

MIAMI (CBSMiami) – The FDA has approved a new drug to treat Alzheimer’s disease, and part of the credit for this discovery goes to doctors at the University of Miami.

Biogen’s aducanumab is given by infusion every four weeks. Researchers say it targets the disease in a way that’s never been done before. The Alzheimer’s Association calls the FDA’s approval historic for patients and their families.

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“It treats the underlying course of the disease. Amyloid is the sticky part that clogs up the brain. By removing that, it is assumed that the individual will have clinical benefit and improvements in cognitive decline,” said Dr. Joanne Pike, chief strategy officer for the Alzheimer’s Association.

Doctors at the University of Miami helped with the research.

Six million americans are currently living with Alzheimer’s disease in the U.S. Until now, other Alzheimer’s drugs only managed symptoms.

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“This treatment ushers in a new era in Alzheimer’s treatments,” said Dr. Pike. “And we know that a first in class drug invigorates the treatment pipeline overall.”

The decision to approve the drug comes despite objections from the FDA’s independent panel of neurological experts. FDA is not required to follow their advice.

Dr. Caleb Alexander is an FDA adviser who recommended against the drug’s approval.

“I think the jury is still out on whether it works. And there is a clear standard that manufacturers have to meet in order to gain market access. And in this instance, I think the evidence is quite murky as to the safety and especially the effectiveness of this product,” said Dr. Alexander.

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The FDA is requiring the drug maker to conduct a follow-up study to confirm benefits for patients. The FDA could pull the drug from the market if the study fails to show effectiveness.

Ted Scouten