FDA approves new Alzheimer's drug; Bucks Co. man discusses experience in clinical trial

Monday, June 7, 2021
FDA approves new Alzheimer's disease drug
The Food & Drug Administration has approved a new drug for Alzheimer's Disease. It's the first in nearly twenty years, but it comes with controversy as some experts advised against

PHILADELPHIA (WPVI) -- The Food & Drug Administration has approved a new drug for Alzheimer's Disease. It's the first in nearly twenty years but it comes with controversy and some experts advised against approving the drug.

There is debate about whether there is enough evidence to show it slows down progression of the disease. The agency says it is the only drug that can likely treat the disease itself and not just the symptoms.

Phil Gutis, 59, of New Hope, Pennsylvania was devastated when he was diagnosed with Alzheimer's Disease.

"I didn't have the mental acuity that I once did," he said.

He enrolled in a clinical trial for a drug, a monthly infusion called Aducanumab. It helps clear amyloid plaque from the brain.

The thought is that will help slow dementia, but similar treatments have failed. Gutis, who did receive the drug and not placebo, believes it's helping.

"My head feels clearer, I don't have my memories back and there are still things I don't remember. My husband feels like in some ways my short term memory has been deteriorating. I am in no way cured but I definitely feel like I am doing better," he said.

The drug, now marketed as Aduhelm, won FDA approval, but the company Biogen is required to continue studies to confirm benefit. Otherwise, the agency could pull the drug from the market.

Alzheimer's Disease affects millions of Americans, including 489,000 older adults in our area according to the Delaware Valley Chapter of the Alzheimer's Association.

The cost emotionally and financially for families is staggering.

Gutis says while this drug may not be perfect, it's an important step forward in research.

"I think it will reopen, and reinvigorate, reenergize the medical community and bio pharm world to delve even further to try to find a better treatment and cure for Alzheimer's," he said.

The drug was tested on people with early-stage Alzheimer's, but it will be up doctors and insurance companies whether patients with more advanced disease can get the drug.