Lilly’s Donanemab Granted FDA Breakthrough Therapy Status

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Lilly’s Donanemab Granted FDA Breakthrough Therapy Status
July 02, 2021July 2, 2021
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The U.S. Food and Drug Administration has named Eli Lilly’s donanemab a breakthrough therapy for treating Alzheimer’s disease, the company announced in a press release. Lilly said it intends to submit a biologics license application or BLA — which would allow it to market donanemab in the U.S. — to the FDA later this year. The breakthrough therapy designation is intended to speed the development and review of treatments for serious medical conditions. To receive such…

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