FibroGen (FGEN) Receives Rare Pediatric Disease Designation from the U.S. FDA for Pamrevlumab for Treatment of DMD
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FibroGen Receives Rare Pediatric Disease Designation from the U.S. FDA for Pamrevlumab for the Treatment of Duchenne Muscular Dystrophy
April 15, 2021 7:00 AM EDTSAN FRANCISCO, April 15, 2021 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease (RPD) Designation for the companys anti-CTGF antibody, pamrevlumab, for the treatment of patients with Duchenne muscular dystrophy (DMD). Pamrevlumab has also received Fast Track designation from the U.S. Food and Drug Administration and is currently being evaluated in two Phase 3 trials for the treatment of DMD. Â
Pediatric patients living with DMD face a significant unmet need with limited treatment options, said Mark Eisner, M.D,... More
