medwireNews: The US FDA has expanded the indication of nintedanib to include systemic sclerosis (SSc)-associated interstitial lung disease (ILD).
The tyrosine kinase inhibitor is the first drug to be approved by the FDA for this condition, and was granted both Priority Review and Orphan Drug designations following results of the phase III SENSCIS trial, which demonstrated a significant reduction in lung function decline among participants treated with nintedanib versus placebo.
Nintedanib, taken orally, has been available for the treatment of idiopathic pulmonary fibrosis since its initial approval in 2014. The label includes warnings for elevated liver enzymes and gastrointestinal conditions, and the FDA cautions that the drug has been linked to embryofetal toxicity and arterial thromboembolic events.
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