FibroGen's Pamrevlumab Gets Orphan Drug Designation To Treat Pancreatic Cancer

(RTTNews) - FibroGen, Inc. (FGEN), a science-based biopharmaceutical company, announced late Wednesday that the U.S. Food and Drug Administration has granted Orphan Drug Designation status to its first-in-class antibody pamrevlumab for the treatment of pancreatic cancer.

Pamrevlumab, formerly FG-3019, is an investigational therapeutic antibody developed by FibroGen to inhibit the activity of connective tissue growth factor or CTGF, a common factor in chronic fibrotic and proliferative disorders characterized by persistent and excessive scarring that can lead to organ dysfunction and failure.

FibroGen is currently conducting clinical studies of pamrevlumab in idiopathic pulmonary fibrosis, pancreatic cancer, and Duchenne muscular dystrophy or DMD.

Orphan Drug Designation qualifies the sponsor for various development incentives of the Orphan Drug Act, and can also convey up to seven years of marketing exclusivity if the compound receives regulatory approval from the FDA.

FibroGen previously received Orphan Drug Designation for pamrevlumab for the treatment of idiopathic pulmonary fibrosis.

Tom Neff, Chief Executive Officer of FibroGen, said, "This is an important regulatory milestone for FibroGen, as pamrevlumab continues to show promise in the treatment of pancreatic cancer. Phase 2 clinical studies of pamrevlumab have produced initial positive data on median and one-year survival for patients with advanced pancreatic cancer."