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

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. Prior to the CAPACITY results, Shionogi & Co. Ltd (Shionogi) had previously presented data from a Phase 3 study conducted in Japan which suggested that pirfenidone positively affected lung function decline and disease progression in patients with IPF. In those clinical studies, pirfenidone was safe and generally well-tolerated, with the most frequent side effects reported being photosensitivity rash and gastrointestinal symptoms. In October of 2008, pirfenidone was approved for use in IPF patients in Japan and is marketed as Pirespa® by Shionogi in that country.

About IPF

Idiopathic pulmonary fibrosis (IPF) is a progressive, debilitating and ultimately fatal disease that affects approximately 200,000 people in Europe and the United States combined, with approximately 30,000 new cases reported per year in each region.


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