FibroGen receives FDA Orphan Drug Designation for FG-3019 to treat IPF

FibroGen, Inc., today announced that FG-3019, the Company's human monoclonal antibody against connective tissue growth factor (CTGF), has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of idiopathic pulmonary fibrosis (IPF).

IPF is a progressive and fatal lung disease for which there are no FDA-approved therapies. FG-3019 was developed to inhibit the activity of CTGF, a matricellular protein that plays a key role in fibrosis. More than a decade of research conducted by FibroGen and others has established the critical role of CTGF as a final common pathway in chronic fibrotic diseases, in which persistent and excessive scarring leads to organ dysfunction and failure.

Orphan Drug Designation is generally granted to drugs or biologics intended for treatment of rare diseases and disorders, i.e., those affecting fewer than 200,000 people in the U.S. This designation conveys special incentives to the sponsor, including tax credit for fifty percent of the cost of clinical trials, prescription drug user fee waiver, and seven years of U.S. market exclusivity for the drug or biologic upon FDA approval.

"The granting of FibroGen's request for Orphan Drug Designation constitutes a major milestone in the development of FG-3019 for pulmonary fibrosis," said Thomas B. Neff, Chief Executive Officer of FibroGen. "We have been encouraged by early results from our ongoing phase 2 studies suggesting that sufficiently high bloodstream levels of FibroGen's FG-3019 antibody may prevent predicted decline in lung function and even increase lung capacity in some cases. We are committed to further clinical evaluation of FG-3019 in hopes of developing a safe and effective therapy that will provide IPF patients with a superior treatment outcome."