FDA approves Donanemab for Alzheimer’s treatment

The FDA has recently approved Donanemab, a monoclonal antibody designed to slow the progression of early symptomatic Alzheimer’s disease. Donanemab is made by Eli Lily, an Indianapolis-based pharmaceutical company.

The drug works by helping the body remove amyloid plaque buildup in the brain, which is the main cause of the disease.

Dr. David Weidman, from the Banner Alzheimer’s Institute, joined “Arizona Horizon” to discuss more about Donanemab.

“It actually is not even enhancing the immune system; it itself is creating a reaction with inflammation but the immune system up there is part of it, but not the body’s immune system. Only one or two percent of this antibody crosses the blood brain barrier,” said Dr. Weidman. 

The drug slows down the process of Alzheimer’s, but the drug itself can’t completely cure the disease. 

“Research now after 20 or 30 years of trying to find antibodies and other treatments that would modify the disease in a sense of slowing down the decline, we finally achieved the concept of reversing gears or curing which means halting, that is a story for a future day,” said Dr. Weidman. 

Dr. Weidman added the treatment group had a 40% decline in Alzheimer’s with the Donanemab compared to the placebo group. 

“The trial evidence which led to FDA approval was giving this drug monthly anywhere from nine to 19 times each month, cause some people were able to, by lowering the amyloid to a nearly non-detectable level, were converted over to just saline salt water placebo and didn’t even know it. And that slowing down of decline in what’s called a treatment group of over 800 people was about on the main measurement 40% less decline than the decline in the placebo group,” said Dr. Weidman.