Nintedanib to treat interstitial lung disease in Europe

May 9, 2020 0 By FM

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.