Successful trials for nintedanib for Idiopathic Pulmonary Fibrosis - Boehringer

Results from the Phase III INPULSIS trials, published online in the New England Journal of Medicine, show nintedanib from Boehringer, significantly slowed disease progression in patients with Idiopathic Pulmonary Fibrosis (IPF). Nintedanib is the first targeted treatment for IPF to consistently meet the primary endpoint in two international Phase III trials with identical design.

IPF is a debilitating and fatal lung disease, with a median survival of 2�3 years after diagnosis. It causes progressive scarring of the lungs, resulting in continual and irreversible deterioration in lung function and difficulty breathing. The average IPF patient has a lung function loss, measured by forced vital capacity (FVC), of 150�200mL per year.

In the two 52 week INPULSIS trials, involving 1,066 patients, nintedanib significantly reduced the annual decline in FVC by approximately 50% compared to patients taking placebo. The annual rate of FVC decline in the two trials was: �INPULSIS�-1: -114.7mL (nintedanib*) vs. -239.9mL (placebo) INPULSIS�-2: -113.6mL (nintedanib*) vs. -207.3mL (placebo).

Both key secondary endpoints were met in the INPULSIS-2 trial. There was significantly less deterioration in quality of life (measured by the St. George�s Respiratory Questionnaire) and a reduced risk of a first acute exacerbation in patients taking nintedanib versus placebo.

See-"Efficacy and Safety of Nintedanib in Idiopathic Pulmonary Fibrosis"- -Luca Richeldi, M.D et al. New England Journal of Medicine May 2014 DOI: 10.1056/NEJMoa1402584.