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New Alzheimer’s drug gets full FDA approval

Alzheimer Drug
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TULSA, Okla. — A major milestone in the fight against Alzheimer’s disease. A new drug, shown to slow the progression of Alzheimer's in the early stages, got full regulatory approval from the Food and Drug Administration.

“The declines of Alzheimer’s they come rapidly,” said Natalie Spreiter. “They come unexpectedly, and so time is of the essence.”

Natalie Spreiter is a Nuclear Medicine Technologist at PET Imaging of Tulsa. The equipment at their Tulsa facility helps them pinpoint beta-amyloid plaques in the brain, which are an indicator of Alzheimer’s Disease.

“You can see how the frontal lobe looks,” said Spreiter. “You lose the undulations. It looks like it’s a little bit blooming.”

Spreiter says the work done at their center in Tulsa was a vital part of the clinical trial that helped get Leqembi full approval from the Food and Drug Administration. She says patients also have to show they have the amyloid plaques in the brain before they can get the Leqembi infusion.

“What it’s designed to do is remove the plaques from the brain in hopes that it can slow down the symptoms of Alzheimer’s,” said Spreiter.

The work is personal for Natalie Spreiter. Her mom, Sue Ann, was diagnosed with Alzheimer’s about 6 years ago.

“When you have Alzheimer’s, it’s just a race against time,” said Spreiter. “If Leqembi would have been available to her 6 years ago, she might not be at the end stage of Alzheimer’s now.”

The Alzheimer’s Association says Leqembi is the first drug fully approved by the FDA that actually helps slow down the disease in the early stage. Studies show it slowed down cognitive decline by about 5 months.

“While this is not a cure for Alzheimer’s disease, it does buy people in those very early stages some longer time for independence,” said Dr. Sarah Coats.

Dr. Sarah Coats is a neuropsychologist that does testing to diagnose different forms of dementia. She says more than 67,000 people in Oklahoma have Alzheimer’s and this new drug is a step in the right direction to actually treat the disease instead of just the symptoms.

“While this medication may not be the silver bullet for curing Alzheimer’s disease, we do hope it’ll be an important part in the overall combination of therapies that we will develop over the years to come,” said Dr. Coats.

In January, when the FDA gave the drug accelerated approval, one of the biggest hurdles was cost. The more than $26,000 price tag was out of reach for most families. Now with full approval, Medicare will be able to cover the drug.

“It removes the barrier that was in place of the high cost of this drug,” said Jacob Guinan, Community Outreach Coordinator for the Alzheimer’s Association Oklahoma Chapter. “It made it inaccessible to a lot of people.”

This decision by CMS is momentous in the fight against Alzheimer’s disease. The approved coverage for Medicare recipients will significantly increase availability for a promising medication that represents hope for hundreds of thousands of families coping with the heartbreaking impact of Alzheimer’s.
Oklahoma Attorney General Gentner Drummond

If you’d like access to Alzheimer’s resources, you can get 24/7 help from the Alzheimer’s Association or call 1-800-272-3900.

If you’d like more information on PET Imaging of Tulsa, visit here or call 918-523-7200.

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