InterMune Inc, Brisbane, Calif, has achieved positive results from its pivotal phase 3 clinical trial of Pirfenidone, which could pave the way for the first FDA-approved therapy to treat pulmonary fibrosis (PF).
The Coalition for Pulmonary Fibrosis (CPF) is calling this a historic day in the research and treatment of PF and urges the US Food and Drug Administration to review InterMune’s new drug application as soon as possible, given that there are no current FDA-approved treatments for PF.
"For patients living with a lethal and ultimately fatal disease, these data indicate that Pirfenidone may allow them breathe better, walk further, and live longer," says Mark Shreve, CPF founder and chief operating officer. "If approved, Pirfenidone would represent a historic and desperately needed advance in the treatment of PF."
"While this study does not represent a cure, it is a historic first step in treating PF and is a shining ray of hope for the thousands of patients suffering from this terrible disease," says Mishka Michon, chief executive officer of the CPF.