BTN News: The U.S. Food and Drug Administration (FDA) has approved donanemab. This is a new antibody treatment. It is meant to slow the early symptoms of Alzheimer’s disease. Eli Lilly makes this drug. It will be sold as Kisunla. It helps remove amyloid plaque from the brain. This plaque is linked to Alzheimer’s.
Details About the Drug and Its Costs for Treatment
Eli Lilly said Kisunla will cost $695 per vial before insurance. This means a six-month treatment will cost about $12,522. A full year of treatment will cost around $32,000. Donanemab is not a cure. But, tests showed it can slow Alzheimer’s. This helps people stay independent longer. They can do daily activities safely.
Results of Clinical Trials and Effectiveness
In June, Eli Lilly shared trial data with the FDA. The results were positive. People taking donanemab had a 35% lower risk of disease progression. This was over 18 months compared to those taking a placebo. The FDA said the drug is safe and works well.
Safety Concerns and Measures for Serious Adverse Events
Some serious side effects happened in the trials. These were rare, affecting only 2% of patients. More people died in the donanemab group (2%) than in the placebo group (1.7%). Three patients died after developing ARIA. ARIA is a type of brain bleed linked to amyloid. After these cases, Eli Lilly added extra MRI checks. This is to find ARIA before the second dose. This helps to pause treatment if needed.
Comparing Donanemab with Other Approved Alzheimer’s Treatments
Kisunla is not the first drug of its kind. Other drugs like Leqembi by Eisai and Biogen, and Aduhelm by Biogen, also treat early Alzheimer’s. Aduhelm was the first to get FDA approval in 2021. But, it will soon stop being made. Leqembi showed fewer ARIA cases than donanemab. Leqembi costs about $26,500 a year. Kisunla costs more.
Future Prospects and Importance of Early Detection and Diagnosis
Eli Lilly says early detection and diagnosis are key. This helps treatments like donanemab work better. They are working with others to improve these processes.
Wider Impact of Alzheimer’s Disease on Patients, Families, and Caregivers
Alzheimer’s affects many older people in the U.S. The Alzheimer’s Association says one in three seniors dies from Alzheimer’s or other dementia. This is more than deaths from prostate and breast cancer combined. The number of people with Alzheimer’s could reach 14 million by 2060.
The Role of Caregivers and the Importance of New Treatments
Alzheimer’s also affects families and caregivers. In 2022, over 11 million unpaid caregivers gave 18 billion hours of care to people with Alzheimer’s and other dementias. New treatments like Kisunla give hope to these families.
Conclusion
The Alzheimer’s Association is happy about the FDA’s approval of Kisunla. Having more treatment options is important. Dr. Joanne Pike, President and CEO, said this approval gives people more time. She called it progress against this hard and devastating disease.
