FDA approves new Alzheimer’s drug following clinical trial at Washington University

Missouri

ST. LOUIS – Government health officials approved a drug to combat Alzheimer’s disease on Monday. It’s the first new Alzheimer’s medication to receive approval from the Food and Drug Administration in nearly 20 years.

However, the approval follows debate in the medical community about whether the drug, aducanumab, actually works in slowing the disease.

“It’s very exciting because this is the first new drug we’ve had for Alzheimer’s in 18 years,” said Dr. Joy Snider, a neurologist who directed the clinical trial at Washington University School of Medicine in St. Louis

Dr. Snider says the drug attacks the underlying brain changes that cause Alzheimer’s instead of just addressing symptoms.

“In Alzheimer’s disease, abnormal proteins accumulate in the brain and one of these chemicals is call beta amyloid, and this drug can remove the beta amyloid from the brain,” she said. “The question is if you do that, does that improve memory and thinking, or stop memory and thinking from getting worse? So that is what we still need to find out.”

According to Snider, patients are eager to try the drug.

“Oh, absolutely. I mean, the phones at our clinic have already been ringing off the walls,” she said. “There are 13 million people in the US who suffer from Alzheimer’s disease and they all want treatment.”

The FDA did give its approval of the drug for patients in the early stages of Alzheimer’s who have mild symptoms, even though an FDA advisory committee last year said that there is not enough evidence to support the effectiveness of the treatment. It may be months before the monthly intravenous drug is available.

“The really good news here is this is just the first drug among many that are coming through the pipeline and, hopefully, what this means is that in the next year or five years, we’ll have many more drugs and may be some of them alone or in combination with each other will help us stop this disease,” Snider said.

The FDA granted approval of the drug on the condition that manufacturer, Biogen, conduct additional clinical trials.

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