FDA Approves New Drug to Help Early-Stage Alzheimer’s Disease

News 6 - January 11, 2023 6:55 am

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The FDA approves a new drug to help people with mild or early-stage Alzheimer’s disease.

Oklahoma’s Alzheimer’s Association said initially, the only people who will have access to the drug are patients who pay out of pocket.

This is exciting news for many outreach organizations and families who know the ugly reality of Alzheimer’s disease.

However, many experts said the drug is pricey, comes with potential health risks like brain swelling and bleeding, and some wonder whether the drug will make a noticeable difference in patients with dementia.

The only memories Jeff Heeley has of his grandma are of her in a care facility and not knowing who he was. That was Jeff’s first experience with Dementia. Then about six years ago, his father-in-law Bob was diagnosed with Alzheimer’s.

“Never talked to a stranger. Breaks my heart to know that for the last you know year, year and a half, two years of his life, everyone was a stranger,” said Jeff.

Jeff and his wife became caregivers.

“‘How do I know you?’ She said, ‘You’re my dad,’ and he’s like, ‘Oh that’s why I love you so much.’ Like I knew I loved you I just didn’t know why,” said Jeff.

Bob died from the disease last summer.

“I think about this most recent drug and again how it can prolong life and I can’t imagine if he had been able to take the medication over the last five years,” said Jeff.

The FDA approved the new drug, Leqembi, which requires twice a month infusions and appears to slow the cognitive decline in patients in early stages of Alzheimer’s.

It will cost more than $26,000 a year.

“Amyloid is, we know, one of the proteins that builds up and is a hallmark of Alzheimer’s disease. And this drugs works by clearing that out,” said Jacob Guinam, OK Alzheimer’s Association.

However, because federal officials said there’s not enough evidence for the drug’s effectiveness, it’s not covered by Medicare or Medicaid.

“Right now, the only people who are going to have access to this drug that really is a game changer for Alzheimer’s are the people who can pay for it out of pocket,” said Guinam.

The FDA approval came via its Accelerated Approval pathway.

The agency said it’ll receive results for review from Phase 3 of the clinical trial soon, and depending on those, it could lead to lower costs.

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