13 November 2017 - - Ridgefield, Connecticut-based Boehringer Ingelheim Pharmaceuticals, the largest US subsidiary of Boehringer Ingelheim Corp., has released results from a descriptive Phase IIIb lung imaging study providing evidence that Ofev (nintedanib) slowed the fibrotic process versus placebo in people with idiopathic pulmonary fibrosis (IPF), the company said.
The primary endpoint of this randomized, double-blind, placebo-controlled, descriptive trial was change in relative QLF score, which uses high resolution CT imaging to measure the extent of lung fibrosis (thickening and scarring of the lungs), from baseline to 6 months of treatment.
The study showed a reduction in the development of lung fibrosis among people treated with Ofev, as measured by quantitative lung fibrosis (QLF) score. Lower QLF scores indicate less fibrotic progression in the lung.
In this study, the QLF score from baseline to 6 months was 11.4% in people treated with Ofev versus 14.6% in the placebo group (difference 3.2%, exploratory endpoint not statistically significant).
A secondary endpoint of the trial was absolute mean change in forced vital capacity (FVC), a measure of lung function.
At baseline, mean FVC was 2997 mL among people treated with Ofev and 2921 mL among people on placebo. The adjusted mean absolute changes in FVC from baseline to month 6 were −14.2 mL and −83.2 mL in the Ofev and placebo groups, respectively.
The US Food and Drug Administration approved Ofev for the treatment of idiopathic pulmonary fibrosis on October 15, 2014. Ofev is one of the first FDA-approved drug treatments for IPF and the only known kinase inhibitor approved to treat this disease.
Boehringer Ingelheim Pharmaceuticals is the largest US subsidiary of Boehringer Ingelheim Corp., headquartered in Ingelheim, Germany. The company operates globally with approximately 50,000 employees in three business areas including human pharmaceuticals, animal health, and biopharmaceutical contract manufacturing.