Contents
Conclusions
- Nintedanib had an acceptable safety and tolerability profile in children and adolescents with fibrosing ILD, with no new safety signals observed compared with adults.
- The exposure achieved with weight-based dosing was within the range observed in adults treated with 150 mg bid.
- Changes in FVC % predicted and SpO2 over 24 weeks favoured nintedanib, but the trial was not powered for these exploratory endpoints.
- These data provide a scientific basis for the use of nintedanib in children and adolescents with fibrosing ILD (aged 6-17 years).