Wednesday, May 31, 2023

Lecanemab Approved for Treatment of Early Alzheimer's Disease

 

The Food and Drug Administration (FDA) recently granted accelerated approval to a new Alzheimer’s treatment called Lecanemab, which has been shown to moderately slow cognitive and functional decline in early-stage cases of the disease. The FDA’s decision followed results of a Phase III clinical trial published in the Jan. 5 issue of The New England Journal of Medicine. Christopher van Dyck, MD, director of Yale’s Alzheimer’s Disease Research Unit, was the lead author of the paper.

Sold under the brand name Leqembi and made by Eisai in partnership with Biogen Inc., the drug is delivered by an intravenous infusion every two weeks.


How Lecanemab works?

Lecanemab is a monoclonal antibody that targets amyloid, a protein that forms sticky plaques in the brain and is a key characteristic of Alzheimer’s disease. The drug binds to the amyloid protein, preventing it from clumping together and forming plaques. It also promotes the clearance of existing plaques, which may reduce inflammation and neuronal damage in the brain.

Several trials of lecanemab have shown positive results in reducing amyloid plaques in the brain. One study found that patients receiving high doses of the drug had a 90% reduction in amyloid plaque levels after 18 months of treatment, compared to placebo. Another study showed that patients receiving lecanemab had a significant reduction in amyloid plaques after just 6 months of treatment. These findings suggest that lecanemab has the potential to slow or even halt the progression of Alzheimer’s disease by reducing the amount of amyloid in the brain.

In addition to reducing amyloid plaques, lecanemab may also improve cognitive function in patients with Alzheimer’s disease. An analysis of data from a phase 2 trial showed that patients receiving the drug had better scores on cognitive tests than those receiving placebo, particularly in tasks related to memory and language. These results suggest that lecanemab may have a positive impact on cognitive function in patients with Alzheimer’s disease.

One key concern in developing drugs for Alzheimer’s disease is the risk of side effects. Previous drugs that targeted amyloid have had limited success in clinical trials, in part because of side effects such as swelling and bleeding in the brain. However, studies of lecanemab have reported few adverse events, and the drug appears to be well-tolerated in patients. This is an encouraging finding, as it suggests that lecanemab may be a safe and effective option for treating Alzheimer’s disease without causing serious side effects.

What were the results of the phase 3 clinical trial?

This is one of the largest clinical trials in Alzheimer's disease and was unique in that it had higher participation of historically underrepresented groups than in previous studies.  It also allowed volunteers with more medical comorbidities to enter the study. Usually, participant populations in studies like these are healthy, so this created a more representative sample of the Alzheimer's population in the real world.

The volunteers underwent a battery of tests that measured cognitive performance, functional performance, and behavior, and brain imaging and monitoring of biomarkers of the disease. The drug was associated with extremely robust amyloid plaque clearance; most of the participants at 18 months had no detectable plaques in their brain. Other downstream effects associated with Alzheimer’s, like tau and neuronal inflammation biomarkers, also looked like they moved more towards normal.

There was a statistically significant separation between participants who received the drug compared to those who received a placebo on global measures of cognitive and functional impairment, keeping in mind that participants in the study had a confirmed diagnosis of Alzheimer’s but their cognitive symptoms were still very mild at the time of their enrollment.  This provides the first definitive evidence that clearing amyloid beta improves cognitive performance.  It is important to note that both groups experienced cognitive decline over the 18 months of the study, but the placebo group declined at a faster rate. 

About 12.5 percent of participants showed evidence of mild to moderate localized brain swelling, but this was not life threatening, rarely clinically evident, and resolved over several weeks when the medication was temporarily halted. We also saw a higher rate of micro hemorrhages, or pinhead bleeds, that we often see in patients with Alzheimer's disease, so the treatment requires careful clinical and MRI monitoring, particularly in the first 6-12 months.


Who should take this drug?

The FDA prescribing information specifies that lecanemab is appropriate for people with early Alzheimer's with confirmation of elevated beta-amyloid. The treatment was studied in people living with early Alzheimer's dementia and MCI due to Alzheimer's who showed evidence of a buildup of beta-amyloid plaques in the brain. The therapy has not been tested on people with more advanced stages of Alzheimer's or those without clinical symptoms.

How much will this drug cost?

In a news release, the manufacturers of lecanemab announced they are setting the price of the drug at $26,500 a year.

How is this drug administered?

The treatment is administered through an IV every two weeks, lasting 45 to 60 minutes for each infusion. Typically, infusions can be done at hospitals and infusion therapy centers.

 

Sources and Additional Information:

https://www.yalemedicine.org/news/lecanemab-leqembi-new-alzheimers-drug

https://www.urmc.rochester.edu/news/story/what-you-need-to-know-about-lecanemab-the-potential-new-alzheimers-drug

https://www.nbcnews.com/health/health-news/new-alzheimers-drug-will-cost-26500-year-will-able-get-rcna64883

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