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The efficacy of pirfenidone in patients with idiopathic pulmonary fibrosis (IPF) was evaluated in three Phase 3, randomized, double-blind, placebo-controlled, multicenter trials (Studies 1, 2, and 3).
Study 1 was a 52-week trial comparing the efficacy of pirfenidone at a daily dose of 2403 mg (n=278) with placebo (n=277) in IPF patients. Studies 2 and 3 were nearly identical in design, with a few exceptions, including the inclusion of an intermediate-dose treatment group in Study 2. Study 2 compared pirfenidone at a daily dose of 2403 mg (n=174) or pirfenidone at a daily dose of 1197 mg (n=87) with placebo (n=174), while Study 3 compared pirfenidone at a daily dose of 2403 mg (n=171) with placebo (n=173). The study drug was administered three times daily with meals for a minimum of 72 weeks. Patients continued treatment until the last patient completed the 72-week treatment period, which included study treatment observation up to approximately 120 weeks. The primary endpoint was the change from baseline to the end of the study in percentage of predicted forced vital capacity (%FVC), measured at Week 52 in Study 1 and at Week 72 in Studies 2 and 3.
Studies 1, 2, and 3 enrolled adult patients with clinically and radiologically diagnosed IPF (with or without surgical lung biopsy), with no evidence or suspicion of other interstitial lung disease diagnoses. Eligible patients had a baseline %FVC of ≥ 50% and a baseline percentage of predicted diffusing capacity of the lung for carbon monoxide (%DLco) of ≥ 30% (Study 1) or ≥ 35% (Studies 2 and 3). In all three trials, more than 80% of patients completed the study treatment.
Across these three trials, a total of 1247 IPF patients were randomized to receive pirfenidone at a daily dose of 2403 mg (n=623) or placebo (n=624). Baseline characteristics were generally balanced across treatment groups.
FDA，2023.02
