InterMune, Inc has submitted an electronic New Drug Application (NDA) with the US Food and Drug Administration (FDA) seeking approval to market pirfenidone for the treatment of patients with idiopathic pulmonary fibrosis (IPF). Pirfenidone has been granted Orphan Drug and Fast Track designation by the FDA, and also has been granted Orphan Drug status in Europe.
"IPF is a rapidly and uniformly fatal disease. Sadly, there are no medicines approved for the approximately 100,000 Americans who suffer from this terrible disease," said Dan Welch, chairman, chief executive officer and president of InterMune. "InterMune has dedicated almost ten years to the development of new medicines for patients with IPF. We are very proud to have submitted the first NDA ever submitted to the FDA for a medicine to treat IPF patients."
Preclinical and in-vitro evidence had shown that pirfenidone has both anti-fibrotic and anti-inflammatory effects.
InterMune is a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and hepatology.