Summary: An independent panel has recommended that Eli Lilly’s Alzheimer’s drug, Donanemab, be approved by the FDA. The drug has shown promise in slowing early-stage Alzheimer’s despite risks like brain swelling.
This recommendation follows a prior FDA rejection due to insufficient data. If approved, Donanemab could revolutionize Alzheimer’s treatment, offering new hope for patients and their families.
Key Facts:
- Donanemab has demonstrated effectiveness in slowing early-stage Alzheimer’s.
- Despite adverse effects like brain swelling, benefits outweigh the risks.
- The FDA previously rejected Donanemab due to insufficient data but is now reconsidering.
Source: Neuroscience News
An independent panel of advisors has recommended that Eli Lilly’s Alzheimer’s disease drug, Donanemab, be approved by the FDA.
If approved, the drug would be the second of its kind to enter the US market, paving the way for better treatment and management for the neurodegenerative disease.
In a unanimous decision, the panel of 11 members declared that based on the available clinical data, Donanemab has demonstrated its effectiveness in treating early-stage Alzheimer’s, effectively slowing down the progression of the disease.
Despite clinical data showing adverse effects of taking Donanemab, including brain swelling and a slightly elevated mortality risk, the benefits of taking the medication significantly outweigh the risks.
The recommendation is a hopeful first step. Early this year, drug company Eli Lilly faced disappointment when the drug failed to gain FDA approval. In January, the FDA rejected the drug, claiming insufficient data to support approving Donanemad at that time.
Donanemad is a monoclonal antibody medication that targets amyloid plaques, a hallmark of Alzheimer’s disease. This helps to slow disease progression and symptoms in those with early-stage Alzheimer’s. The drug is administered via intravenous infusion on a monthly basis.
However, it is advised to note that Donanemab is not a cure for Alzheimer’s, and does have significant side effects. During trials, three patients died from amyloid-related imaging abnormalities or ARIA.
Phase three trial data collected from over 1,700 patients revealed that Donanemab slowed the progression of Alzheimer’s pathology by 29% over 18 months compared to a placebo.
Those with low-to-medium levels of the Tau protein in neuroimaging data fared better from the treatment than those with higher levels of Tau. However, Eli Lilly argued that eligibility for the drug should be based on amyloid levels, not Tau. Advisors agree with Lilly’s stance, saying that testing for Tau levels could potentially restrict the number of patients for whom the drug could be accessible.
During the trial, those whose levels of amyloid in the brain dropped below a specific threshold were eligible to switch to a placebo. At the end of the trial, 60% of patients were able to effectively stop Donanemab treatment.
If approved, the FDA will include a “strong boxed warning” relating to the potential side effects, including brain bleeds and death, especially for those who carry two copies of the APOE4 gene.
This recommendation provides hope for the treatment of Alzheimer’s disease, especially for those who are in the early stages.
About this Alzheimer’s disease and neuropharmacology research news
Author: Neuroscience News Communications
Source: Neuroscience News
Contact: Neuroscience News Communications – Neuroscience News
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