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InterMune Announces Posting of Briefing Documents for FDA Advisory Committee Meeting on Pirfenidone
Date:3/5/2010

the safety and efficacy of pirfenidone in IPF patients on a number of clinical measures.  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 pirfenidone may positively affect lung function 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 & Co. Ltd. in that country.

About IPF

IPF is characterized by inflammation and scarring (fibrosis) in the lungs, hindering the ability to process oxygen and causing shortness of breath (dyspnea) and cough and is a progressive disease, meaning that over time, lung scarring and symptoms increase in severity. The median survival time from diagnosis is two to five years, with a five-year survival rate of approximately 20%. Patients diagnosed with IPF are usually between the ages of 40 and 70, with a median age of 63 years and the disease tends to affect slightly more men than women.

About InterMune


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5. InterMune Announces Submission of NDA for Pirfenidone for the Treatment of Patients with IPF
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