FDA Fast-Tracks Pamrevlumab for Idiopathic Pulmonary Fibrosis
FibroGen announced that the Food and Drug Administration (FDA) has granted Fast Track designation to pamrevlumab for the treatment of patient with idiopathic pulmonary fibrosis (IPF).
Pamrevlumab, a first-in-class anti-connective tissue growth factor (CTGF) human monoclonal antibody, works by inhibiting the activity of CTGF. CTGF is a common mediator involved in the progression of fibrotic and proliferative disorders that cause persistent and excessive scarring.
The FDA's designation was based on data from a Phase 2 placebo-controlled trial that demonstrated pamrevlumab could potentially address an unmet medical need for this condition. Through the Fast Track pathway, the Company will have more frequent interactions with the Agency during the drug development process.
Phase 3 studies for IPF are anticipated to start in early 2019. Pamrevlumab has previously been granted Orphan Drug designation for IPF and pancreatic cancer. The drug is also being investigated in a Phase 2 trial for Duchenne muscular dystrophy (DMD).
For more information visit FibroGen.com.