Abeona Therapeutics receives Breakthrough Therapy designation status from FDA
Story excerpt provided by Crain’s Cleveland Business.
Abeona Therapeutics Inc. (Nasdaq: ABEO), a clinical-stage biopharmaceutical company, announced that the U.S. Food and Drug Administration has granted Breakthrough Therapy designation status to the company’s EB-101 gene therapy technology for patients with Recessive Dystrophic Epidermolysis Bullosa, or RDEB.
The designation “enables collaborative discussions with senior FDA personnel, priority review and an expedited approval process to drug candidates where preliminary clinical trials indicate that a therapy may offer substantial treatment advantages over existing options for patients with serious or life-threatening diseases,” according to a news release from Abeona, which has offices in Cleveland, New York and Dallas.
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Originally published August 29, 2017.
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