Boehringer Ingelheim announced that the Food and Drug Administration (FDA) has granted Fast Track designation to nintedanib (Ofev) for the treatment of systemic sclerosis associated with interstitial lung disease (SSc-ILD). 

Systemic sclerosis (also known as scleroderma) is a disease in which the connective tissue of multiple organs start to thicken and scar. Most patients with this disease will develop lung scarring or ILD. “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,” stated Robert Riggs, CEO of the Scleroderma Foundation. 

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The designation was supported by the Investigational New Drug application (IND) for the treatment of SSc-ILD and the anticipated safety and efficacy data from the Phase 3 double-blind, randomized, placebo-controlled SENSCIS (Safety and Efficacy of Nintedanib in Systemic SClerosIS) trial that included over 520 patients. The study evaluated the safety and efficacy of nintedanib 150mg twice daily for 52 weeks (max 100 weeks), with the primary endpoint being annual rate of decline in forced vital capacity (FVC). Major secondary endpoints included the absolute change from baseline in the modified Rodnan Skin Score (mRSS) and the Saint George’s Respiratory Questionnaire (SGRQ) total score. 

Ofev, a kinase inhibitor, is currently approved to treat idiopathic pulmonary fibrosis (IPF). It is supplied as 100mg and 150mg strength capsules.

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