Nintedanib Designated Orphan Drug for Scleroderma, Associated ILD
The Food and Drug Administration (FDA) has granted Orphan Drug designation to nintedanib (Boehringer Ingelheim) for the treatment of systemic sclerosis (SSc, or scleroderma), including the associated interstitial lung disease (SSc-ILD).
Scleroderma is a rare and serious autoimmune disease characterized by thickening and scarring of connective tissue of multiple organs in the body, including the skin and lungs. The disease may become life-threatening and fatal when lung involvement, such as in SSc-ILD, is present.
The Company is evaluating nintedanib in the SENSCIS (Safety and Efficacy of Nintedanib in Systemic SClerosIS) study, a randomized, double-blind, placebo-controlled trial designed to assess its efficacy and safety over 52 weeks up to a maximum of 100 weeks in patients with SSc-ILD. The primary endpoint is the annual rate of decline in forced vital capacity (FVC), a measure of disease progression.
Nintedanib is a kinase inhibitor previously approved and marketed as Ofev for the treatment of idiopathic pulmonary fibrosis (IPF).
For more information call (800) 542-6257 or visit Boehringer-ingelheim.com.