FDA's PADAC meeting to review pirfenidone NDA: InterMune posts briefing documents

InterMune, Inc. (Nasdaq: ITMN) announced today that the U.S. Food and Drug Administration (FDA) has posted briefing documents for the March 9 Pulmonary-Allergy Drugs Advisory Committee (PADAC) meeting to review the New Drug Application (NDA) for pirfenidone, InterMune's investigational drug candidate for the treatment of patients with idiopathic pulmonary fibrosis (IPF) to reduce decline in lung function.  The proposed trade name for pirfenidone is Esbriet®.

IPF is a disabling and ultimately fatal disease that affects approximately 200,000 people in the United States and Europe combined, with approximately 30,000 new cases reported per year in each region.  There are no medicines approved in the United States or in Europe for the treatment of IPF.  Pirfenidone was approved in Japan in October of 2008 and is marketed by Shionogi & Co. Ltd as Pirespa®.

The Advisory Committee meeting is scheduled for 8:00 a.m. EST on Tuesday, March 9, 2010. The briefing materials can be accessed at:  http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Pulmonary-AllergyDrugsAdvisoryCommittee/ucm199877.htm

Pirfenidone Regulatory Path – NDA and MAA

On November 4, 2009, InterMune submitted the NDA for pirfenidone to the FDA, seeking approval to market pirfenidone for the treatment of patients with IPF to reduce decline 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.

SOURCE InterMune, Inc.

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