South Florida expert on what you need to know about new Alzheimer's drug
MIAMI - A new Alzheimer's drug will soon hit the market after gaining FDA approval Tuesday.
Donanemab is meant to slow the rate of a brain's decline in the early stages of the disease.
According to a press release from drugmaker Eli Lilly and Company, which will market donanemab as Kisunla, the medication "slowed cognitive and functional decline by up to 35% compared to placebo at 18 months in its pivotal Phase 3 study and reduced participants' risk of progressing to the next clinical stage of disease by up to 39%."
Dr. James Galvin is a Professor of Neurology at the University of Miami's Miller School of Medicine.
While this approval is welcome news for patients and clinicians, he stresses it is not a cure for the disease.
"It provides some symptomatic benefits. Some people progress slower, but because it's removing the amyloid protein, which we believe is the initial trigger for Alzheimer's disease, Donanemab will help modify the disease. So people who get treated can eventually clear the amyloid from their brain," he explained to CBS News Miami's Lauren Pastrana. "A large proportion of the patients who were treated in the trial by 12 to 18 months had no evidence of amyloid in their brain."
Because Alzheimer's is a very complex disease, Dr. Galvin said it would likely take a cocktail or combination of different medications attacking different parts of the disease to get us closer to a cure.
"There are over 160 clinical trials involving over 150 different medications that are currently being tested for Alzheimer's disease," Dr. Galvin said. "Some are symptomatic that means they're treating only the symptom of the disease, but a whole bunch of them are what we think will be disease-modifying medications."
As part of CBS News Miami's ongoing "Illuminating Alzheimer's" coverage, we've been following one local patient for over a year as she takes part in a clinical trial of an Alzheimer's drug.
Sury Veliz is part of a blind study, so she doesn't know which medication she's taking, or whether she's receiving a placebo.
But she's hopeful for more treatment options and ultimately a cure.
"I'm going to fight. I have to fight," Veliz said. "I have seen improvements. My girls have seen improvements. They're like, oh my God, you remember that. Oh, ok. I remember that!"
For over a year, Veliz has been driving weekly from her home in Key Largo to a clinic in Miami to get her medication. It's a 140-mile roundtrip.
She was diagnosed 5 years ago and found the study online.
"The shots hurt, so I try not to think about it because I can make myself pass out because of fear. So I don't think about it," she said. "I don't want to be doing this all in vain. But like I said, I don't think I am. I think we're on the verge of something really great."
As with many medications, there are possible side effects which could range from an allergic reaction to swelling, and even hemorrhage or seizures.
Experts say patients should be monitored with MRIs through treatment.
This approval has been a long-time coming, but last year the FDA asked the drugmaker for more information before ultimately deciding the benefits outweigh the risks.
Dr. Galvin stresses the roll out of this intravenous medication will take time, so it may not be available to all patients right away.
According to Eli Lilly and Company, the price of a vial of Kisunla will be $695.65.
