Guest guest Posted December 18, 2009 Report Share Posted December 18, 2009 According to their press release, InterMune Inc announced that it submitted a New Drug Application (NDA) with the FDA, seeking approval to market Pirfenidone for the treatment of patients with IPF. Pirfenidone has been granted Orphan Drug and Fast Track designation by the FDA. InterMune has dedicated almost ten years to the development of new medicines for patients with IPF. This is the first NDA ever submitted to the FDA for a medicine to treat IPF patients. Preclinical and in-vitro evidence had shown that pirfenidone has both anti-fibrotic and anti-inflammatory effects. Results from three adequate well-controlled Phase 3 studies have shown evidence of a treatment effect in IPF patients and the compound has been safe and generally well tolerated. In Oct 2008 Pirfenidone was approved for use in IPF patients in Japan and is marketed as Pirespa by Shionogi in that country. [The Pulmonary Paper] My question is...when a NDA has been submitted how long does it take to get approval and market? C_53_Familial IPF_5/09, Washington HOPE doesn't disappoint! Quote Link to comment Share on other sites More sharing options...
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