Eli Lilly (LLY) announced that the Food and Drug Administration granted Breakthrough Therapy designation for donanemab, its investigational antibody therapy for Alzheimer's disease. Lilly intends to submit a biologics license application for donanemab under the accelerated approval pathway later this year based on data from TRAILBLAZER-ALZ.
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The safety, tolerability and efficacy of donanemab are also being evaluated in the ongoing Phase 3 study TRAILBLAZER-ALZ 2, the company said in a statement. The Phase 2 trial, TRAILBLAZER-ALZ, studied the efficacy and safety of donanemab in patients with early, symptomatic Alzheimer's. Shares of Eli Lilly are up 9%, or $18.50, to $235.60 following the news.
Shares of Biogen (BIIB), who recently received FDA approval for its Alzheimer's treatment, are down 6% to $350.02 in premarket trading.
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