Posted by Michael Wonder on 27 Oct 2017
Prometic receives fast track designation for PBI-4050 in development for idiopathic pulmonary fibrosis
25 October 2017 - Fast track designation follows recent FDA approval of pivotal Phase 2/3 clinical trial in IPF.
Prometic Life Sciences today announced that the U.S. FDA has granted Fast Track designation to PBI-4050, a clinical candidate in development for idiopathic pulmonary fibrosis (IPF). The Fast Track designation follows the FDA’s recent approval of Prometic’s investigational new drug application and design of the pivotal Phase 2/3 clinical trial in patients with IPF.
“The treatment options for patients with fibrotic diseases like IPF are limited in scope and effectiveness,” said Pierre Laurin, president and chief executive officer of Prometic. “Fast Track designation will allow us to advance PBI-4050 and seek to potentially gain approval in a more efficient process. PBI-4050 has the potential to provide patients with IPF a more effective treatment option. We look forward to demonstrating PBI-4050’s clinical efficacy and strong safety and tolerability profiles in a longer-term, placebo controlled trial.”
