FDA grants full approval for Alzheimer's drug. New hope but not without risks

• The FDA has approved a drug, Leqembi, shown to slow the progression of Alzheimer’s in patients in the early stages of the illness
• Michigan reported having 190,000 Alzheimer’s patients over the age of 65 in 2020
• Alzheimer’s currently has no cure, and significantly worsens over time

The Food and Drug Administration granted traditional approval for a new drug, Leqembi, made to treat Alzheimer's patients Thursday. The drug helps reduce the amount of amyloid plaques in the brain, one of the physical symptoms of the disease, and slow down the rate of decline, albeit modestly.

Alzheimer’s is the most common cause of dementia, a general term for memory loss – 6.5 million Americans currently have Alzheimer’s. Michigan reported having 190,000 Alzheimer’s patients over 65 in 2020, and is estimated to have 220,000 patients in the same age category by 2025. Of those over age 70 with the disease, 61 percent are expected to die before the age of 80 compared to 30 percent of people over age 70 who don’t have Alzheimer’s. The disease, which worsens significantly over time, has no cure.

Related:

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• 1-in-10 people in U.S. over 65 has dementia, U-M study finds
• Hope or hype? Costly new Alzheimer’s drug creates controversy

To Jean Barnas, program director for the Michigan chapter of the Alzheimer’s Association, this medication marks a new hope for Alzheimer’s patients and their families.

“I’ve been working with the association for 22 years, and there’s never been really anything like this where it gives really excitement, hopefully some time back for individuals in the early stages, and really just more of an option to take a medication that can help with changing the course of the disease,” Barnas told Bridge Michigan.

Leqembi slows cognitive and functional decline in patients living with the disease. Another drug, Aduhelm, targets the amyloid plaques like Leqembi. However, when it was approved by the FDA in June 2021 based on preliminary results from clinical trials, the drug faced controversy from those who wanted more evidence to prove its safety. A month later, the FDA limited Aduhelm usage from all patients to only those in the earliest stages of the disease, a decision that was supported by the Alzheimer’s Association.

Clinical trials for Leqembi were restricted to those in the early stages of the illness, as the drug’s primary purpose is to slow the progression of the illness. This is the reason that the drug is not available for those in later stages.

While the medication marks new hope for patients struggling with Alzheimer’s, it is currently only available for those who can prove that they have amyloid plaque in their brain, which requires an MRI. The approval means that Medicare is going to cover the medication for patients, though specific costs of a patient will depend on their insurance plan.

The medication also comes with some side effects, including amyloid related imaging abnormalities (ARIA), which according to Barnas is a slight swelling in the brain that can cause dizziness, headaches, and other symptoms.

Dr. Amit Sachdev, the medical director of the Michigan State University Department of Neurology and Ophthalmology and the principal investigator for the drug’s trial at MSU, said the drug does bring some hope, but those interested in it should pay attention to these side effects.

“While there’s reason to be optimistic, there are major risks around bleeding and brain swelling with the treatment,” Sachdev said in a press release. “These risks need to be very carefully considered. Patients will need solid evidence that they have Alzheimer’s and need to have easy access to emergency care if they choose to go on the drug. Brain swelling and bleeding are very serious side effects and minor neurologic symptoms, such as dizziness and headache, could be due to such swelling.” 

Leqembi may not be set on curing Alzheimer’s patients, and it may not be available for all those currently struggling with the illness, but to Barnas, the drug means progress.

“It’s not like the silver bullet but it’s a huge step in the right direction,” Barnas said. “It’s just like uncovering more and more research, it’s reinvigorating the science community…this is just one piece of the Alzheimer’s puzzle.”