The leading web portal for pharmacy resources, news, education and careers

February 9, 2010

Pharmacy Choice - Pharmaceutical News - InterMune seeks FDA approval for pirfenidone for treatment of idiopathic pulmonary fibrosis - February 9, 2010

Pharmacy News Article

11/4/09 - InterMune seeks FDA approval for pirfenidone for treatment of idiopathic pulmonary fibrosis

4 November 2009 - US-based biotechnology company InterMune Inc (NASDAQ: ITMN) said on Wednesday it has filed 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.

The company licensed pirfenidone from Marnac Inc and its co-licensor, KDL GmbH, in 2002 and in 2007 purchased from Marnac and KDL the rights to sell the compound in the United States, Europe and other territories except in Japan, Taiwan and South Korea where rights to the molecule were licensed by Marnac and KDL to Shionogi & Co Ltd of Japan. In October 2008, pirfenidone was approved for use in IPF patients in Japan and is marketed as Pirespa by Shionogi in that country.

((Comments on this story may be sent to tww.feedback@m2.com))