This week, a US Food and Drug Administration (FDA) advisory committee endorsed the safety and efficacy of Eli Lilly and Co.’s (NYSE: LLY) donanemab, a biologic therapy that targets amyloid plaques, for its use in treating early symptomatic Alzheimer’s disease (AD). The recommendation follows a request from the regulator earlier in the year for additional evaluation, prompted by the observed risk of potentially fatal amyloid-related imaging abnormalities (ARIA).
The committee’s support is grounded in Phase III clinical trial data, which demonstrated that donanemab reduced the risk of disease progression by 37% over a period of 1.5 years when compared to a placebo. While the treatment was found to increase the mortality rate by 0.3%, the committee concluded that the benefits of donanemab surpass the risks.
The FDA will proceed with its assessment of the medicine, with a final decision anticipated to be made after the fourth quarter of 2024.- Flcube.com
