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The European Medicines Agency Completes Validation Stage for InterMune's Marketing Authorization Application for pirfenidone
Date:3/23/2010

d would expand its commercial infrastructure to support European marketing efforts. Given the significant unmet medical need for medications to treat patients with IPF, the approval of pirfenidone in Europe would represent a second and important value-creation opportunity to that represented by the U.S. market.

U.S. Regulatory Status

The New Drug Application (NDA) for pirfenidone was submitted by InterMune to the United States Food and Drug Administration (FDA) in early November 2009. 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. Based on the Prescription Drug User Fee Act, the FDA has set an action date for the NDA of May 4, 2010. On March 9, the FDA's Pulmonary-Allergy Drugs Advisory Committee (PADAC) voted 9-3 to recommend the approval of pirfenidone for the treatment of U.S. patients with IPF to reduce decline in lung function.

About Esbriet® (pirfenidone)


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