Interim analysis supports phase III data for Ofev (nintedanib) in idiopathic pulmonary fibrosis- Boehringer Ingelheim

An interim analysis of the INPULSIS-ON open-label extension trial of Ofev (nintedanib), from Boehringer Ingelheim, shows efficacy and safety that is consistent to that in the two identically-designed Phase III INPULSIS trials in patients with idiopathic pulmonary fibrosis (IPF). The results show no relevant changes in the safety and tolerability of nintedanib. The results also suggest that treatment has a long-term effect (approximately two years) on slowing disease progression across both pivotal and open-label trials (as measured by annual rate of forced vital capacity [FVC] decline).

These new data are important particularly because IPF is a rare and serious lung disease, and people with IPF may be on therapy for an extended period. No new safety signals were identified following long-term treatment with nintedanib in INPULSIS-ON. Adverse events were reported in 92.8 percent and 96.7 percent of patients continuing with and initiating nintedanib, respectively. Serious adverse events were reported in 41.9 percent and 39.5 percent of these same patients. The results were presented at the European Respiratory Society Congress 2015.

Comment: Pirfenidone (Esbriet) from Intermune/Roche is a competitor to nintedanib and both are FDA-approved to treat idiopathic pulmonary fibrosis.