Home » FDA Approves New Alzheimer’s Drug: Hope and Risks for Early-Stage Patients

FDA Approves New Alzheimer’s Drug: Hope and Risks for Early-Stage Patients

by Richard A Reagan

The U.S. Food and Drug Administration (FDA) has approved a new drug, Kisunla (donanemab), aimed at treating Alzheimer’s disease

This approval is a significant development for patients in the early stages of this debilitating condition, offering a glimmer of hope alongside notable risks.

In clinical trials, Kisunla showed promise in slowing cognitive decline in patients with mild cognitive impairment (MCI) or early-stage Alzheimer’s

The drug, developed by Eli Lilly, is administered monthly through intravenous infusions. Notably, it targets amyloid plaques in the brain, which are believed to contribute to Alzheimer’s progression. 

Anne White, executive vice president and president of Lilly Neuroscience, highlighted the importance of early treatment. 

“Kisunla demonstrated very meaningful results for people with early symptomatic Alzheimer’s disease, who urgently need effective treatment options. We know these medicines have the greatest potential benefit when people are treated earlier in their disease,” White stated in a company news release.

Dr. Howard Fillit, co-founder and chief science officer at the Alzheimer’s Drug Discovery Foundation, hailed the approval as a significant step forward. 

“This approval marks another step forward in evolving the standard of care for people living with Alzheimer’s disease that will ultimately include an arsenal of novel treatments, providing much-needed hope to the Alzheimer’s community,” Fillit remarked.

The drug is similar to another treatment, Leqembi, which was approved last year. Both drugs slow dementia by targeting amyloid plaques. 

However, Kisunla offers the advantage of potentially stopping treatment once the plaques are cleared, potentially reducing costs and side effects. 

In trials, Kisunla showed that it could significantly slow the progression of Alzheimer’s. Patients on Kisunla saw a slower cognitive decline even after discontinuing the drug, with 17% of patients stopping treatment after six months, 47% after a year, and 69% after 18 months.

Dr. Charles Bernick from the Cleveland Clinic Lou Ruvo Center for Brain Health noted the benefits of Kisunla’s targeted approach. 

“Donanemab is an antibody that specifically targets the amyloid plaques that occur in Alzheimer’s disease and causes their removal. Studies show that removal of the plaques by donanemab can slow the progression of the disease.”

Despite its promising benefits, Kisunla carries significant risks. 

About one-fourth of patients experienced brain swelling or bleeding, with 2% facing serious side effects linked to three deaths during the trials. 

Dr. Marc Siegel, clinical professor of medicine at NYU Langone Medical Center, cautioned about these risks, noting that while similar to Leqembi, Kisunla might offer a marginally better outcome in slowing Alzheimer’s progression.

The financial aspect is another concern. 

Kisunla is priced at $32,000 per year, higher than Leqembi’s $26,000. However, since Kisunla treatment can be stopped once the amyloid plaques are cleared, the overall cost and treatment burden might be lower in the long run.

While the approval of Kisunla is a significant advancement, some experts express concerns about the focus on anti-amyloid drugs. 

Dr. Michael Greicius, a neurologist at Stanford University, warned that the emphasis on these treatments might hinder progress in exploring other potential therapies. 

Research continues on various fronts, with dozens of drugs in clinical trials targeting different aspects of Alzheimer’s, such as tau tangles and neuroinflammation.

The FDA‘s approval of Kisunla offers new hope for patients with early-stage Alzheimer’s, despite the associated risks and costs.

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