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InterMune Announces Submission of MAA for Pirfenidone for the Treatment of Patients With IPF
Date:3/2/2010

n">the United States in early November 2009. The U.S. Food and Drug Administration's (FDA) Pulmonary-Allergy Drugs Advisory Committee (PADAC) is scheduled to discuss the company's NDA for pirfenidone on March 9, 2010.  Based on the Prescription Drug User Fee Act (PDUFA), the FDA has set an action date for the NDA of May 4, 2010.

On January 4, 2010, InterMune announced that the FDA granted Priority Review designation for its New Drug Application (NDA) for pirfenidone for the treatment of IPF.  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.  

About Pirfenidone

Preclinical and in-vitro evidence has 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 the safety and efficacy of pirfenidone in IPF patients on a number of clinical measures.  Prior to the CAPACITY resul
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SOURCE InterMune, Inc.
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