New Solutions Needed for Alzheimer’s Disease as Economic Costs and Safety Concerns Surge

March 22, 2023 -

While the Alzheimer’s Association current estimates that 6.7 million Americans over 65 (or more than 1 in 9 seniors) are now living with Alzheimer’s Disease (AD), it’s expected that the burden of those affected will double over the next two decades, rising to 13 million in 2050.

The economic threat of such a surge in numbers is real—as there’s a shortage of capable caregivers, and unpaid dementia caregiving is being valued at $340 billion. With birth rates plummeting around the world, replacing these caregivers may be even more challenging over the coming decades than they are now.

Those who would be suffering from AD in 2050 would likely be of the tail end of Generation X and smackdab in the middle of Millennials. So between now and then, something major needs to change in terms of care and prevention of Alzheimer’s Disease and/or Dementia.

Thankfully, there’s still plenty of research under way to not only treat the disease if diagnosed, but also to halt its progression as soon as it shows up.

Researchers at Rochester University’s School of Medicine are currently exploring whether the onset of symptoms can be delayed, or even prevented. The university is one of 70 institutions taking part in the National Institutes of Health’s funded Ahead Study.

The study is using the FDA’s first approved drug proven to reduce beta amyloid plaque build up in the brain and the slow onset of Alzheimer’s disease. The drug in question is lecanemab-irmb, better known by its brand name LEQEMBI, which was granted Accelerated Approval back in January 2023.

“Alzheimer’s disease immeasurably incapacitates the lives of those who suffer from it and has devastating effects on their loved ones,” said Billy Dunn, M.D., director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research. “This treatment option is the latest therapy to target and affect the underlying disease process of Alzheimer’s, instead of only treating the symptoms of the disease.”

The FDA had also given Accelerated Approval for another Alzheimer’s treatment back in 2021, with Aducanumab (brand name Aduhelm). While both Aducanumab and Lecanemab were developed by the same group, the difference comes in the delivery, with Aducanumab working by removing beta-amyloid from the brain, while Lecanemab blocks the formation of amyloid plaques in the brain.

Now the developers are working to achieve a traditional approval from the FDA, with Lecanemab’s application has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of July 6, 2023.

However, there is a bit of a potential issue developing behind the approval of lecanemab, which originally gained its FDA nod amid safety concerns. The drug comes with warnings that highlight lecanemab’s potential for brain swelling and bleeding called ARIA (amyloid-related imaging abnormalities). It’s recommended that anyone taking lecanemab have three MRIs in roughly the first 6 months of treatment to watch for these types of side effects.

Add on top of these concerns, another major concern arose when Billy Dunn (quoted above) stepped down from his role, amid allegations he had an inappropriately cozy relationship with the controversial drug Aducanumab’s developers. Dunn had been with the agency for roughly 18 years, last as the Head of the FDA’s neuroscience office.

Back in 2020, the FDA's independent advisory committee voted nearly unanimously (11 of 12 committee members, with one voting "uncertain") that the agency should not approve the drug. Yet, the approval went through anyway, and Aduhelm's maker went on to set the exorbitant price of $56,000 for a year's worth of treatment.

Third-party researchers called the approval "disgraceful," while three advisory members resigned in protest, and Medicare Part B premiums rose by record amounts to accommodate covering the pricey drug for Alzheimer's patients desperate for new treatments.

These concerns haven’t deterred groups such as Veterans Affairs which agreed to cover the cost of Leqembi, while the Alzheimer’s Association has lobbied for Medicare coverage of Leqembi.

"Treatments taken in the early stages of Alzheimer’s would allow people more time to participate in daily life, remain independent and make health care decisions for their future," said Joanne Pike, President of the Alzheimer’s Association.

Subsequent media and congressional investigations alleged that Aduhelm’s approval was secured through an FDA back channel with Dunn two years prior, which sparked an unusually close collaboration in the lead-up. For example, one congressional report released in December 2022 found that some portions of the developer’s documents regarding the drug were actually written by the FDA itself, and that the agency worked with the company to create briefing documents together.

The congressional report’s conclusion was that the FDA failed to follow its own rules in its "atypical" interactions with the developer and that it "inappropriately collaborated" with the company. It also called Aduhelm's price "unjustifiably high."

Thus the future of the currently-approved Alzheimer’s Disease treatments is seemingly unknown at this point, while the market and the disease’s sufferers await potential other solutions. Thankfully, there are several other promising treatments with very different profiles that are under development, with plenty of updates expected to come out as 2023 rolls on.