- Nintedanib oral capsules for treating chronic fibrosing (scarring) interstitial lung diseases (ILD) with progressive characteristics have gotten approval from the US Food and Drug Administration (FDA).
- The drug lessens lung function decline.
Why this matters
- The move represents the first approval for this group of fibrosing lung diseases that worsen over time.
- The European Medicines Agency Committee for Medicinal Products for Human Use recommends approval.
- FDA had previously approved nintedanib for ILD associated with systemic sclerosis or scleroderma.
- The approval was based on the Lancet-published INBUILD trial, a randomized, double-blind, placebo-controlled trial held over 52 weeks at 153 sites in 15 countries (n=663).
- With 150 mg oral capsules twice daily, nintedanib was associated with a decreased annual rate of decline in FVC vs placebo of 107 (95% CI, 65.4-148.5) mL/year (P<.001>
- The most common adverse events were diarrhea, nausea, stomach pain, vomiting, liver problems, decreased appetite, headache, and weight loss.
- The FDA does not recommend the drug for patients with moderate or severe hepatic impairment.
- Nintedanib may cause embryo-fetal toxicity in the form of arterial thromboembolic events, bleeding, and gastrointestinal perforation, among others.