Privately-held German drugmaker Boehringer Ingelheim has announced results from an interim analysis of the SENSCIS-ON trial evaluating Ofev (nintedanib) in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD).
In September 2019, Ofev was approved in the USA as the first and only therapy to slow the rate of decline in pulmonary function in patients with SSc-ILD, a rare autoimmune disease characterized by thickening and scarring of connective tissue throughout the body. The disease is estimated to affect about 100,000 people in the USA and 2.5 million worldwide.
SENSCIS-ON is an open-label extension trial to assess the long-term tolerability and safety of Ofev in patients with SSc-ILD who completed the Phase III SENSCIS trial. The study also evaluated the change from baseline in forced vital capacity (FVC) as a measure of lung function over 52 weeks.
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