Guest guest Posted December 18, 2009 Report Share Posted December 18, 2009 It can vary widely within a range from as little as 6 months to as much as 3 years with the norm being 9 - 24 months from what I've found. Pirfenidone does have orphan drug status in their favor in the approval process but also has the less than hoped for results of the trials working against them, especially failing to meet the goal in one of the two trials. The FDA had agreed to a fast-track process on Pirfenidone, which typically is six months or thereabouts. So, based on the application being submitted in November of this year, I would have expected an answer by May, 2010. But the failure of Capacity 1 could complicate matters. Note that it took Intermune a much longer than anticipated time just to put the application together after the completion of the trials. I still think a decision is likely sometime between May and September, 2010, but thats not by any means set in stone. Now, to go off topic a bit. I'm not a Pirfenidone proponent so stating this from a general rather than a specific situation. I find the approval time from the point of application to the point of approval or rejection to be absurdly long. It seems to me that the requirements should be known and the documents submitted should either meet or fail to meet those requirements. It doesn't take 2-3 years to review, but it's more a matter of backlog and of getting additional information. Those matters just shouldn't be there. If it fails to meet requirements then it should be rejected, not go back and forth for years. Let them resubmit at a later date if they can meet requirements. Similarly, if a med does meet requirements, then it shouldn't take so long to see that if the application is properly prepared. I do realize the volume is extremely high. This timeframe has been extremely problematic as cancer drugs are submitted, many hopeful of curing the disease, as opposed to Pirfenidone which even at best is only hopeful of slowing a disease. Yes, the approval process is thorough to protect us, but thorough doesn't have to be slow. > > 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 Japanand 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...
Guest guest Posted January 14, 2010 Report Share Posted January 14, 2010 Hi Everyone,Do any of you happen to know when we can expect pirfenidone to be approved by the FDA? Or how to find that information. It was approved in Japan 10-16-08, and is supposed to be a great medication in stopping fibrosis. Maybe if we all sent messages to the FDA they would move faster.Pat Quote Link to comment Share on other sites More sharing options...
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