Exhibit 99.1
FIBROGEN RECEIVES FAST TRACK DESIGNATION FROM THE U.S. FDA FOR PAMREVLUMAB FOR THE TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS
SAN FRANCISCO, California, September 12, 2018 – FibroGen, Inc. (NASDAQ: FGEN), a biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the company’s anti-CTGF antibody, pamrevlumab, for the treatment of patients with idiopathic pulmonary fibrosis (IPF). This follows review of the Phase 2 clinical data evaluating pamrevlumab in a placebo-controlled trial and represents recognition by the FDA that pamrevlumab has the potential to address an unmet medical need for this disease.
“This Fast Track designation reflects recognition of the great need for a new therapeutic to help patients diagnosed with IPF to reduce the burden and progression of this debilitating disease and another positive step in developing pamrevlumab for the treatment of IPF,” said Elias Kouchakji, M.D., Senior Vice President, Clinical Development and Drug Safety. “We look forward to advancing pamrevlumab into Phase 3 studies early next year.”
About Fast Track Designation
Fast Track designation is intended to facilitate the development and review of drugs used to treat serious conditions and to fill an unmet medical need. Fast Track designation enables the company to have more frequent interactions with the FDA throughout the drug development process, so that an approved product can reach the market expeditiously.
About Idiopathic Pulmonary Fibrosis
IPF is a form of progressive pulmonary fibrosis, or abnormal scarring of the lungs. As tissue scarring progresses, transfer of oxygen into the bloodstream is increasingly impaired, leading to irreversible loss of lung function, as well as high morbidity and mortality rates. Average life expectancy is estimated to be three to five years from diagnosis with approximatelytwo-thirds of patients dying within five years. Survival rates are comparable to those of some of the deadliest cancers.
Patients with IPF experience debilitating symptoms, including shortness of breath and difficulty performing routine functions, such as walking and talking. Other symptoms include chronic dry, hacking cough, fatigue, weakness, discomfort in the chest, loss of appetite, and weight loss. Over the last decade, refinements in diagnosis criteria and enhancements in high-resolution computed tomography (HRCT) imaging technology have enabled more reliable diagnosis of IPF without the need for a lung biopsy.
IPF is designated as an orphan disease by the U.S. Food and Drug Administration, with U.S. prevalence and incidence estimated to be 135,000 cases (defined byICD-9 code) and 21,000 new cases per year, respectively, based on Raghu et al. (Am J Respir Crit Care Med, 2006) and on data from the United Nations Population Division. We believe the number of patients will continue to grow due to heightened awareness and improved methods for detection and diagnosis.
