FDA Approves Eli Lilly's Alzheimer's Treatment Donanemab
FDA Approves Donanemab for Early Alzheimer’s Treatment.
Disclaimer: The information provided in this article is based on current knowledge and scientific understanding as of the date of publication. This content does not constitute medical advice and should not be used as a substitute for professional consultation with a healthcare provider.
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On Tuesday, the U.S. Food and Drug Administration (FDA) approved Donanemab, a monoclonal antibody developed by Indianapolis-based pharmaceutical company Eli Lilly. Designed to slow the progression of early-stage symptomatic Alzheimer's disease, this approval marks a massive milestone in the battle against one of the most debilitating neurodegenerative disorders affecting millions of people worldwide.
Donanemab works by targeting and helping the body eliminate amyloid plaques in the brain. These plaques are considered a hallmark of Alzheimer's disease and contribute to the cognitive decline observed in patients. By reducing these plaques, Donanemab aims to slow the progression of Alzheimer's, thereby allowing patients to maintain their independence and participate safely in everyday activities for a more extended period. The drug will be marketed under the name Kisunla and comes with a hefty price tag. Each vial costs $695 before insurance, amounting to approximately $12,522 for a six-month course or around $32,000 for a year, depending on the patient's treatment timeline. Although expensive, the cost reflects the complexity and innovation behind Kisunla's development.
Eli Lilly presented late-stage clinical research data to an FDA advisory committee in June, showing "highly meaningful results" for those who took Donanemab. Patients experienced a 35% lower risk of disease progression over 18 months compared to those who received a placebo. Based on these findings, the FDA advisers concluded that the treatment appeared to be both safe and effective.
Safety Concerns and Adverse Events
Despite its promising results, Donanemab is not without risks. Serious adverse events occurred in 2% of the trial participants. The mortality rate was slightly higher among those taking Donanemab—2% compared to 1.7% in the placebo group. Notably, three patients died after developing amyloid-related imaging abnormalities (ARIA), which are micro-hemorrhages in the brain. Most ARIA incidents occurred within the first six weeks of the trial. As a precaution, Eli Lilly added an additional MRI exam before administering the second dose to detect asymptomatic ARIA. If detected, treatment would be paused to allow the condition to resolve, thus preventing it from becoming more serious or symptomatic.
Kisunla is not the first monoclonal antibody treatment approved for early Alzheimer's. Eisai and Biogen’s Leqembi (lecanemab) is already in use, and Biogen's Aduhelm (aducanumab) received accelerated FDA approval in 2021. However, Biogen has announced plans to discontinue Aduhelm production by the end of the year to focus resources on its other Alzheimer's treatments. In clinical trials, Leqembi also showed instances of ARIA, albeit at a lower rate than observed with Donanemab. Despite these complications, both drugs have shown potential in slowing disease progression, providing hope for patients and families affected by Alzheimer's.
Prescribing Guidelines
The FDA's approval of Kisunla includes specific guidelines for prescribers. Physicians may consider discontinuing treatment if brain scans indicate improvement, potentially lowering out-of-pocket costs for patients. This feature distinguishes Kisunla from other treatments like Leqembi, which costs approximately $26,500 per year. Given that these medications are most effective during the early symptomatic stage of Alzheimer's, Eli Lilly is collaborating with other organizations to improve early detection and diagnosis. "Each year, more and more people are at risk for this disease, and we are determined to make life better for them," said Anne White, executive vice president and president of Lilly Neuroscience.
According to the Alzheimer's Association, one in three older Americans dies with Alzheimer's disease or another form of dementia, a statistic that presents the urgent need for effective treatments. Alzheimer's claims more lives annually than prostate and breast cancer combined, highlighting its devastating impact on public health.
The FDA's approval of Donanemab offers new hope in the fight against Alzheimer's disease. Although not a cure, this medication represents a advancement in managing early-stage symptoms and prolonging the quality of life for those affected. While challenges remain, including high costs and potential side effects, the approval of Kisunla is a critical step toward better treatment options for Alzheimer's patients.
Disclaimer: The information provided in this article is based on current knowledge and scientific understanding as of the date of publication. This content does not constitute medical advice and should not be used as a substitute for professional consultation with a healthcare provider.
Real-time information is available daily at https://stockregion.net