New phase III trial results for Vargatef/Ofev (nintedanib) in idiopathic pulmonary fibrosis-Boehringer

Boehringer announced new post-hoc analyses from the Phase III INPULSIS trials of Vargatef/Ofev (nintedanib) in idiopathic pulmonary fibrosis (IPF). The first analysis showed treatment with Ofev has similar and consistent effects on disease progression (as measured by annual rate of forced vital capacity [FVC] decline) and the amount of time to the first acute exacerbation -- regardless of whether people with IPF enrolled in the trials in the U.S. or internationally. Adverse events were reported in 100 percent and 98.4 percent of U.S. patients; and 94.6 percent and 88.1 percent of non-U.S. patients in the OFEV and placebo groups, respectively.

The second new analysis, showed comparable efficacy with Ofev treatment on slowing disease progression, regardless of the presence of extensive lung scarring (or honeycombing) on imaging tests at diagnosis. The two subgroup analyses were presented at the American College of Chest Physicians Annual Meeting (CHEST 2015) in Montreal, Canada.