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MN experts, Alzheimer’s family advocates respond to latest FDA decision

On Jan. 6, the FDA approved Lecanemab – which will be marketed as Leqembi – saying the drug marks a dramatic improvement from previous treatment options.

ST PAUL, Minn. — Local experts and others in the Alzheimer’s community welcomed the recent decision by the Food and Drug Administration to approve a new Alzheimer’s medication, saying the drug marks a dramatic improvement from previous treatment options.

On Jan. 6, the FDA approved Lecanemab – which will be marketed as Leqembi – using the Accelerated Approval pathway, and after showing promising results in an 18-month study.

“Because this trial was effective in showing that this drug slowed disease progression in terms of cognitive decline and functional decline by 27 percent, compared to placebo, this drug was approved by the FDA,” explained Dr. Michael Rosenbloom, clinical director for HealthPartners Center for Memory and Aging in St. Paul.

A neurologist’s perspective 

Rosenbloom contrasted the performance of this medication to Aducanumab, marketed as Aduhelm and approved by the FDA in 2021, based both on effectiveness and severity of side effects. 

“The drug trials have found it to be more effective in slowing the decline than Aducanumab and, in addition, it’s relatively safer, in terms of these micro-hemorrhages and incidence of brain swelling. It’s not perfect, but we see a trend in the right direction,” Rosenbloom shared with KARE 11’s Karla Hult.

But Rosenbloom also cautioned we still need answers to several outstanding questions, including: How much will the Centers for Medicare and Medicaid Services (CMS) cover of the medication’s $26,500 price tag? And how will health care communities cope with the management of the drug – from scans to monitor the side effects, to the actual transfusion of the medication?

Still, Rosenbloom believes the medication offers the most significant hope in decades – particularly if only prescribed to those without higher risk factors.

“There is the possibility if you kept patients on this drug for longer than 18 months, you may have a cumulative effect. This is certainly much more than we’ve seen for over 20 years-plus,” he said.

And significantly, Rosenbloom also predicts that while this drug may not allow a person to “bounce back to how they were before the diagnosis,” it could end up as a key ingredient in a critical medication cocktail.

“Drugs that affect the disease process at each stage, I think will be beneficial. If you look at the way we treat HIV right now, we have our therapy where we have different drugs that act via different mechanisms to make a difference. And you know HIV is a chronic disease that people live with it doesn’t progress to AIDS, and I see that as the future of Alzheimer’s disease,” Rosenbloom said.

‘It means more time’ 

Meantime, advocates for those living with Alzheimer’s and their families say Lecanemab gives hope in that it also promises to give families more time.

“It means more time. It means days, weeks, months,” said Susan Parriott, CEO of the Alzheimer’s Association, Minnesota-North Dakota chapter.

Parriott pointed out that not only would families enjoy more time with their loved ones, but they would also experience lower costs for caregiving, given that people would spend more time in the earlier stages of the disease – when care is less expensive.

“It is definitely more time with people living in early stage where they can still participate in all kinds of daily activities. Building memories with their families, recognizing their spouses and their loved ones. Going still to work, still driving, helping to make all those important decisions in their life that they want to be part of. Time is so precious, as we know. And having the ability to be really active in your life during that time is really important for people with Alzheimer’s disease,” Parriott said.

To learn more about the resources available to those living with Alzheimer’s, check out the local chapter of the Alzheimer’s Association.

Full disclosure: Karla Hult herself remains an advocate for those on the Alzheimer’s journey after losing her own dad to the cruel disease in 2019. Hult also started So Many Goodbyes as a resource for others on this difficult journey on Father’s Day, 2021.

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