InterMune Inc. (ITMN) said that it has submitted an electronic new drug application with the FDA seeking approval to market pirfenidone for the treatment of patients with idiopathic pulmonary fibrosis or IPF.
Pirfenidone has been granted Orphan Drug and Fast Track designation by the FDA, and also has been granted Orphan Drug status in Europe. InterMune licensed pirfenidone from Marnac Inc. and its co-licensor, KDL GmbH, in 2002 and in 2007 purchased the rights to sell the compound in the United States, Europe and other territories except in Japan, Taiwan and South Korea.
In October of 2008, pirfenidone was approved for use in IPF patients in Japan and is marketed as Pirespa by Shionogi in that country.
Idiopathic pulmonary fibrosis or IPF is a disabling and ultimately fatal disease that affects approximately 200,000 patients in the United States and Europe combined, with approximately 30,000 new cases reported per year in each of the United States and Europe.
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