by In a significant development, the US Food and Drug Administration (FDA) panel of medical experts has endorsed the use of Eli Lilly and Company’s experimental Alzheimer’s drug, donanemab, following three days of intensive deliberations. This recommendation comes after the drug showed promising results in clinical trials, providing hope for millions of Alzheimer’s patients and their families.
The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee voted 14 to 1 in favor of approving donanemab, an antibody therapy designed to target and remove beta-amyloid plaques from the brain. These plaques are believed to contribute to the cognitive decline associated with Alzheimer’s disease.
The panel’s positive recommendation does not guarantee that the FDA will ultimately approve the drug, but it significantly increases the likelihood of approval. The FDA usually follows the advice of its advisory committees, but it is not obligated to do so.
Donanemab has shown remarkable efficacy in clinical trials, with patients receiving the drug experiencing a slower rate of cognitive decline compared to those in the placebo group. The drug is administered intravenously every four weeks, and Eli Lilly has reported that it can reduce the amount of beta-amyloid plaque in the brain by up to 40%.
The potential approval of donanemab marks a significant milestone in the fight against Alzheimer’s disease, which affects more than 6 million Americans and is expected to affect over 13 million by 2050. If approved, donanemab could become the first disease-modifying therapy for Alzheimer’s since the FDA’s approval of Biogen’s Aduhelm in 2021.
Eli Lilly is planning to submit a Biologics License Application (BLA) to the FDA for donanemab in the coming weeks. If approved, the drug could be available to patients as early as next year.
The FDA’s expert panel has voted to recommend Eli Lilly’s experimental Alzheimer’s drug, donanemab, following promising clinical trial results. The drug, which targets and removes beta-amyloid plaques from the brain, could become the first disease-modifying therapy for Alzheimer’s if approved by the FDA.
