Despite Positive Advisory Committee Vote, InterMune Gets Complete Response For Pirfenidone
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA requests an additional efficacy trial, not surprising given that the IPF drug met the primary endpoint in only one of two Phase III trials.
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InterMune’s pirfenidone and Boehringer Ingelheim’s nintedanib are neck-and-neck in the race to be the first drug interventions in the U.S. for the fatal lung disease. Phase III data from both drugs were presented at the American Thoracic Society meeting and published in the NEJM May 18.
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