Alzheimer’s Drug Receives Accelerated FDA Approval

A medication designed to help slow the progression of early stage Alzheimer's disease in some individuals recently received accelerated approval from the FDA.

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CLEVELAND – According to the CDC, an estimated 6.5 million Americans are living with Alzheimer’s disease – which does not have a cure.

However, researchers are hopeful about a new medication that could possibly help slow its progression in certain individuals. 

“When we say Alzheimer’s, it’s a large spectrum, so there are very early stages to very advanced dementia,” said Babak Tousi, MD, neurogeriatrician for Cleveland Clinic. “So at this point, there are no findings supporting the use of this medication for people with moderate to late stage dementia. This is for people in the very early stages of the disease.”

Dr. Tousi said the medication, which is called Lecanemab, was designed to reduce amyloid beta plaque in the brain.

Amyloid beta plaque has been linked to Alzheimer’s disease.

The medication does not treat symptoms of the disease but rather helps to slow down the progression of it.

As far as success rates go, results from an 18 month clinical trial showed participants who received the medication, had a 27% reduction in amyloid beta plaque.

Dr. Tousi said that number may sound small but he believes it’s a good place to start.

“It seems we have achieved some treatment. We can affect the disease trajectory,” he said. “It is a small benefit, but it still a benefit. We can slow it down and I think it’s one of many [medications] to come down the road to hopefully target it, so that’s the biggest step for us.”

Documented side effects for the medication included edema, which is accumulation of fluid in brain tissue and micro-hemorrhages.  

The FDA recently authorized accelerated approval of the medication, but it will be a while before it’s widely available and covered by insurers.

And again, only certain individuals would be eligible for it.  

**Editor’s note: Dr. Tousi is a paid scientific advisor for Biogen and Eisai.

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