Despite Mixed Views On Efficacy Data, Advisory Committee Recommends Approval Of InterMune's Pirfenidone
This article was originally published in The Pink Sheet Daily
Executive Summary
InterMune's pirfenidone has a May 4 PDUFA date and would be the first drug approved for idiopathic pulmonary fibrosis.
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Despite Positive Advisory Committee Vote, InterMune Gets Complete Response For Pirfenidone
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.
Despite Positive Advisory Committee Vote, InterMune Gets Complete Response For Pirfenidone
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.