Lilly’s donanemab receives U.S. FDA’s Breakthrough Therapy designation for treatment of Alzheimer’s disease

USA – The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for donanemab, Eli Lilly and Company’s investigational antibody therapy for Alzheimer’s disease (AD). The Breakthrough Therapy designation aims to expedite the development and review of drugs that are intended to treat a serious condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on a clinically significant endpoint(s) over already available therapies that have received full FDA approval. The FDA Breakthrough Therapy designation is based on clinical evidence for donanemab, an investigational antibody…

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