Benzinga | Apr 15, 2021 07:02AM EDT

FibroGen Receives Rare Pediatric Disease Designation From The FDA For Pamrevlumab For Treatment Of Duchenne Muscular Dystrophy

FibroGen, Inc. (NASDAQ:FGEN) announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease (RPD) Designation for the company's 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.



"Pediatric patients living with DMD face a significant unmet need with limited treatment options," said Mark Eisner, M.D, M.P.H, Chief Medical Officer, FibroGen. "Obtaining Rare Pediatric Disease Designation is another acknowledgement of the serious and life threatening manifestations of this rare disease, and supports our mission to provide pamrevlumab as a potential new treatment option for patients suffering from DMD."