US FDA gives Fast Track designation to Boehringer Ingelheim’s nintedanib
Boehringer Ingelheim announces the 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 enables development of new therapies that treat serious conditions and fulfil 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.
The study is fully enrolled, including more than 520 patients from 32 countries.
“This Fast Track designation is an encouraging step in our ongoing research and commitment to advancing the care of those with systemic sclerosis with interstitial lung disease,” said Dr Christopher Corsico, Chief Medical Officer, Boehringer Ingelheim. “It is critical that we address the significant unmet medical need of those living with this disease and we are looking forward to working with the FDA to advance the development of this potential therapy.”
Robert Riggs, Chief Executive Officer of the Scleroderma Foundation, added: “There have been no FDA-approved treatment options for scleroderma with lung involvement and very few drugs assessed in clinical trials for a devastating reality for people living with the disease.”
Systemic sclerosis, also known as scleroderma, is a rare disease depicted by the thickening and scarring of the connective tissue of multiple organs in the body, typically affecting women between 25-55 years of age. Most people with the disease will develop some lung scarring, or interstitial lung disease (ILD), which has found to be the leading cause of death among people with systemic sclerosis.
Nintedanib, which is marketed as Ofev, is approved for a rare lung disease called idiopathic pulmonary fibrosis, or IPF, and has been shown to slow disease progression as measured by the annual rate of decline in lung function. Because SSC-ILD and IPF share similarities in how the underlying lung scarring, or fibrosis, forms in people with the disease, Boehringer Ingelheim is evaluating the impact of nintedanib on SSC-ILD.
Source: European Pharmaceutical Review