Understanding the Hurdles: Why Was Donanemab Rejected by Regulatory Agencies?
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5 min read
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.
