ASCEND Phase 3 TrialInterMune provided an update on patient enrollment in the company's Phase 3 "ASCEND" study, which is designed to confirm the efficacy and safety of pirfenidone and to support an NDA re-submission for FDA approval of Esbriet (pirfenidone) in the United States. The company now expects ASCEND to be fully enrolled around the end of 2012. InterMune's previous guidance was the second quarter of 2012.Steve Porter, M.D., Ph.D., Chief Medical Officer for InterMune, said, "Our primary mission for ASCEND is to deliver a high-quality result, which we aim to achieve by concentrating on a select number of high-quality sites. While a number of factors have contributed to the extended timeline, we are firmly convinced that the trade-off between data quality and time is a very good one. We believe the trial design and refined entry criteria of ASCEND significantly increase our probability of a successful outcome because they provide that patients enrolled in the study have the characteristics that we know from our many studies in IPF predict disease progression. We are extremely pleased with the continued enthusiasm of IPF physicians for ASCEND and look forward to sharing the results at the end of the study."
France's Transparency Commission (CT) Issues Favorable Opinion For Reimbursement Of Esbriet® (pirfenidone)
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