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Pirfenidone's long trudge to FDA approval: InterMune launches new trial (ASCEND-3)
Unimpressed by the unimpressive results of the CAPACITY trials testing pirfenidone for idiopathic pulmonary fibrosis, the FDA bucked its advisory panel (which had recommended approval) and insisted on another randomized trial in order to reconsider the drug.
In July 2011 InterMune started enrollment for ASCEND, which plans to provide results on pirfenidone vs. placebo in ~500 patients with IPF in mid-2013. Pirfenidone would not likely be approved until early 2014, according to news reports and press releases.