Alzheimer's drug from Eli Lilly wins backing of FDA committee
What is the mechanism of action of the Alzheimer's drug donanemab developed by Eli Lilly?
Donanemab, developed by Eli Lilly, is a monoclonal antibody targeted against a specific epitope on a form of post-translationally modified amyloid beta (Aβ) plaque, specifically the N-terminus of pyroglutamate Aβ. It exerts its therapeutic effects by clearing amyloid beta (Aβ) plaques in the brain2. These plaques are sticky buildups of protein fragments that accumulate outside neurons, contributing to the cognitive decline and memory loss in Alzheimer's disease. By inducing microglial-mediated clearance of existing Aβ plaques, donanemab aims to slow the progressive decline in cognitive function associated with Alzheimer's Disease.
What are the implications of the FDA advisory committee's recommendation for Eli Lilly in terms of regulatory approval for donanemab?
The FDA advisory committee's recommendation for Eli Lilly's Alzheimer's drug donanemab is a positive development, as it moves the drug one step closer to regulatory approval. The committee's unanimous vote that donanemab is effective at slowing down Alzheimer's in the disease's early stages and that the drug's benefits outweigh its risks, removes a significant hurdle for Eli Lilly in obtaining FDA approval.
While the FDA is not obligated to follow the recommendations of its advisory committees, it often does so. If the FDA follows the committee's recommendation, donanemab would become the second drug of its kind on the U.S. market, following Leqembi from Biogen and Eisai3. This would provide a new treatment option for millions of Alzheimer's patients and their families, offering hope in the fight against this debilitating condition.
However, it is essential to note that the drug also carries significant risks, including brain swelling and bleeding. Approximately 24% of trial participants experienced brain swelling, while 31% experienced brain bleeding, with serious cases occurring in a small percentage of patients. These risks highlight the need for caution, and the FDA is expected to require a strong "boxed" warning on donanemab's label.
In conclusion, the FDA advisory committee's recommendation is a crucial step forward for Eli Lilly in gaining regulatory approval for donanemab. The final decision by the FDA is highly anticipated and could come later this year.
How does donanemab's treatment protocol differ from other anti-amyloid drugs in terms of discontinuing treatment after certain amyloid levels are achieved?
Donanemab, an Alzheimer's drug developed by Eli Lilly, has a unique treatment protocol compared to other anti-amyloid drugs. The drug works by clearing sticky amyloid beta plaques from the brain, which are associated with the progression of Alzheimer's disease. What sets donanemab apart from other anti-amyloid drugs is the possibility of discontinuing treatment once a patient's amyloid levels are reduced to a certain threshold.
This approach assumes that dropping the treatment wouldn't compromise the benefit of the drug, thus reducing the treatment burden on patients. The FDA considers this theory "reasonable," but it is not directly supported by evidence. This feature of Eli Lilly's approach could make donanemab more appealing compared to other anti-amyloid drugs, as it may offer a more targeted and potentially shorter-duration treatment option for patients with mild cognitive impairment and mild dementia due to Alzheimer's disease.