The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Boehringer Ingelheim’s nintedanib for the treatment of systemic sclerosis with associated interstitial lung disease (SSc-ILD). 

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, randomized, placebo-controlled global Phase III trial. This pivotal 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 care of those with systemic sclerosis with interstitial lung disease,” said Christopher Corsico, M.D., 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.”

Systemic sclerosis, also known as scleroderma, is a rare disease characterized by the thickening and scarring of connective tissue of multiple organs in the body, typically affecting women between ages 25 and 55. Most people with the disease will develop some degree of lung scarring, or interstitial lung disease (ILD), which is 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 annual rate of decline in lung function.