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InterMune Announces Posting of Briefing Documents for FDA Advisory Committee Meeting on Pirfenidone
Date:3/5/2010

ne in lung function.  Pirfenidone has been granted Orphan Drug and Fast Track designation by the FDA, and also has been granted Orphan Drug status in Europe.  On January 4, 2010, InterMune announced that the FDA granted Priority Review designation for the pirfenidone NDA.  Priority Review designation may be granted by the FDA to an NDA for drugs that have the potential to offer major advances in treatment, or provide a treatment where no adequate therapy exists.  Based on the Prescription Drug User Fee Act (PDUFA), the FDA has set an action date for the NDA of May 4, 2010.

On March 2, 2010, InterMune announced that it had submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA), seeking approval to market pirfenidone for the treatment of IPF patients in the European Union.

About Pirfenidone

Preclinical and in-vitro evidence have shown that pirfenidone has both anti-fibrotic and anti-inflammatory effects. In February 2009, InterMune announced the results of the company's two global Phase 3 clinical trials evaluating pirfenidone for the treatment of IPF, known as the CAPACITY trials.  InterMune believes that these data support
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SOURCE InterMune, Inc.
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5. InterMune Announces Submission of NDA for Pirfenidone for the Treatment of Patients with IPF
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