Posted by Michael Wonder on 19 Mar 2018
FDA grants fast track designation to nintedanib for the treatment of systemic sclerosis with associated interstitial lung disease
19 March 2018 - The designation is based on the investigational new drug application for SSc-ILD and the anticipated efficacy and safety data from the Phase III SENSCIS trial.
Boehringer Ingelheim announced today that the U.S. FDA has granted Fast Track designation to nintedanib for the treatment of systemic sclerosis with associated interstitial lung disease (SSc-ILD). The FDA’s Fast Track designation facilitates the development of new therapies that treat serious conditions and fulfill an unmet medical need in an effort to get treatments to those in need sooner.
This designation is based on Boehringer Ingelheim’s Investigational New Drug application (IND) of nintedanib for the treatment of SSc-ILD and the anticipated efficacy and safety data from SENSCIS (Safety and Efficacy of Nintedanib in Systemic SClerosIS), a double-blind, randomised, placebo-controlled global Phase III trial. This pivotal study is fully enrolled, including more than 520 patients from 32 countries.
