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FDA Advisory Committee Recommends Approval of InterMune's Esbriet(R) (pirfenidone) for Idiopathic Pulmonary Fibrosis
Date:3/9/2010

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About Esbriet (pirfenidone)

Preclinical and in-vitro evidence has shown that Esbriet 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 Esbriet for the treatment of IPF, known as the CAPACITY trials.  Prior to the CAPACITY results, data had previously been presented from another Phase 3 study and three Phase 2 clinical trials in more than 400 patients which suggested that Esbriet may positively affect lung function and disease progression in patients with IPF.  In those clinical studies, Esbriet 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 & Co. Ltd. in that country.

About IPF


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SOURCE InterMune, Inc.
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