FDA Approves Eli Lilly’s Alzheimer’s Drug Donanemab: A New Hope for Patients
The Food and Drug Administration (FDA) has finally approved Eli Lilly’s Alzheimer’s drug, donanemab, after a long and challenging journey. This milestone marks a significant breakthrough in the treatment of Alzheimer’s disease, a mind-wasting condition that affects nearly 7 million Americans and is the fifth-leading cause of death for adults over 65.
What is Donanemab?
Donanemab is a monoclonal antibody that targets toxic plaques in the brain called amyloid, a hallmark of Alzheimer’s disease. It is administered through monthly infusions and has been shown to slow the progression of the disease by 35% over 18 months compared to a placebo. Patients can stop treatment and switch to a placebo after six, 12, or 18 months if they meet certain goals for amyloid plaque clearance.
Approval and Competition
The FDA approval comes after donanemab faced obstacles in its path to market. The agency initially rejected the drug’s approval due to insufficient data, then delayed it again in March. However, an advisory panel to the FDA recommended the treatment for full approval, stating that the benefits outweigh its risks. Donanemab will compete head-to-head with another treatment from Biogen and Eisai called Leqembi, which has gradually rolled out in the U.S. since it won approval last summer.
How Does Donanemab Work?
Donanemab works by targeting and clearing amyloid plaques in the brain, which are a hallmark of Alzheimer’s disease. It is administered through monthly infusions and has been shown to slow the progression of the disease by 35% over 18 months compared to a placebo. Patients can stop treatment and switch to a placebo after six, 12, or 18 months if they meet certain goals for amyloid plaque clearance.
Cost and Reimbursement
The cost of donanemab is estimated to be $12,522 for a six-month course, $32,000 for 12 months, and $48,696 for 18 months. Medicare coverage and reimbursement are available for eligible patients, Eli Lilly said.
Side Effects and Risks
While donanemab has shown promise in slowing the progression of Alzheimer’s disease, it is not without risks. The drug can cause significant safety risks, including swelling and bleeding in the brain that can be severe and even fatal in some cases. Three patients who took Eli Lilly’s drug in a late-stage trial died from severe forms of these side effects, called amyloid-related imaging abnormalities, or ARIA.
Conclusion
The FDA approval of donanemab is a significant milestone in the treatment of Alzheimer’s disease. This drug offers new hope for patients and their families, providing a potentially effective treatment option for a disease that has long been a challenge to treat. While there are risks associated with donanemab, the benefits of slowing the progression of the disease make it a valuable addition to the treatment landscape.
FAQs
Q: What is donanemab?
A: Donanemab is a monoclonal antibody that targets toxic plaques in the brain called amyloid, a hallmark of Alzheimer’s disease.
Q: How does donanemab work?
A: Donanemab works by targeting and clearing amyloid plaques in the brain, which are a hallmark of Alzheimer’s disease.
Q: What are the benefits of donanemab?
A: Donanemab has been shown to slow the progression of Alzheimer’s disease by 35% over 18 months compared to a placebo.
Q: What are the risks associated with donanemab?
A: Donanemab can cause significant safety risks, including swelling and bleeding in the brain that can be severe and even fatal in some cases.
Q: How much does donanemab cost?
A: The cost of donanemab is estimated to be $12,522 for a six-month course, $32,000 for 12 months, and $48,696 for 18 months.
Q: Is Medicare coverage available for donanemab?
A: Yes, Medicare coverage and reimbursement are available for eligible patients, Eli Lilly said.
Q: What is the competitive landscape for Alzheimer’s treatments?
A: Donanemab will compete head-to-head with another treatment from Biogen and Eisai called Leqembi, which has gradually rolled out in the U.S. since it won approval last summer.
Author: www.cnbc.com
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