InterMune, Inc. (ITMN) recently announced  that the U.S. Food and Drug Administration (FDA) granted a priority review to pirfenidone, its candidate for treating idiopathic pulmonary fibrosis (IPF), a fatal lung disease. The U.S. agency is expected to decide on whether to approve pirfenidone for this indication by May 4, 2010 (action date). Preclinical and in-vitro evidence revealed that pirfenidone possesses both anti-fibrotic and anti-inflammatory effects.
 
In November 2009, InterMune submitted an electronic New Drug Application (NDA) to the FDA, seeking the agency’s approval to market pirfenidone. The FDA has reduced the target period for reviewing the application from around 10 months to 6 months by granting priority review designation to the lung drug. Priority review designation is granted to those drugs that offer major advances in treatment or are indicated for treating diseases where no adequate therapy exists. Pirfenidone enjoys Orphan Drug and Fast Track status in the United States coupled with Orphan Drug status in Europe.
 
Currently, there are no approved therapies for treating IPF in the United States or Europe. The chronic lung disease, which is progressive, disabling and ultimately fatal, affects approximately 200,000 patients in the United States and Europe combined. Approximately 30,000 new cases are reported annually in both the United States and in Europe. IPF is characterized by inflammation and scarring in the lungs. The disease hinders the ability to process oxygen, thereby causing shortness of breath resulting in cough.
 
The drug was licensed by Intermune from Marnac Inc. and KDL GmbH in 2002. Intermune then proceeded to buy the sales rights of pirfenidone in the United States and Europe and some other places excluding Japan, South Korea and Taiwan in 2007. The InterMune lung drug was approved in Japan for treating IPF patients in October 2008. The drug is sold under the name Pirespa in that country by Shionogi & Co. Ltd.
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