Posted by Michael Wonder on 12 Sep 2018
FibroGen receives fast track designation from the U.S. FDA for pamrevlumab for the treatment of idiopathic pulmonary fibrosis
12 September 2018 - FibroGen today announced that the U.S.FDA has granted fast track designation for the company’s anti-CTGF antibody, pamrevlumab, for the treatment of patients with idiopathic pulmonary fibrosis.
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.
Idiopathic pulmonary fibrosis is designated as an orphan disease by the U.S. FDA, with U.S. prevalence and incidence estimated to be 135,000 cases (defined by ICD-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.
