Tag: Amyloid related imaging abnormalities

In clinical trials for the Alzheimer's medication LEQEMBI (lecanemab), up to 12.6% of patients experienced brain swelling (ARIA-E) and 17.3% experienced brain bleeding (ARIA-H), which was higher than in the placebo group. While often asymptomatic, these side effects can, in rare cases, manifest with serious, stroke-like symptoms or lead to fatal brain hemorrhages, raising concerns about if **LEQEMBI can cause a stroke**. The U.S. Food and Drug Administration (FDA) has issued a black box warning to highlight this significant safety risk.

In January 2023, the U.S. Food and Drug Administration (FDA) initially rejected Eli Lilly's application for accelerated approval of its Alzheimer's drug, donanemab, citing a limited number of patients with adequate long-term data. This was not the only regulatory hurdle the treatment would face, as the European Medicines Agency (EMA) also refused authorization later due to an unfavorable risk-benefit assessment.