Nintedanib to treat interstitial lung disease in EuropeMay 9, 2020
Boehringer Ingelheim said the European Commission (EC) has approved nintedanib for the treatment of systemic sclerosis-associated interstitial lung disease (SSc-ILD) in adults.
The approval is based on the results of the SENSCIS trial, a phase III, double-blind, placebo-controlled trial conducted to investigate the efficacy and safety of nintedanib in patients with SSc-ILD. The primary endpoint
was the annual rate of decline in forced vital capacity (FVC) assessed over a 52-week period.
Results showed nintedanib slowed the loss of pulmonary function by 44% (41mL/year) relative to placebo, as measured in FVC over 52 weeks.