Nintedanib Approved for Rare Lung Disease

The FDA has approved Nintedanib (Ofev, Bohringer Ingelheim Pharmaceuticals) to slow the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD). 

Nintedanib is an oral kinase inhibitor originally approved by the FDA in 2014 for the treatment of idiopathic pulmonary fibrosis. 

Effectiveness in slowing the decline of pulmonary function in patients with SSc-ILD was measured in a randomized, double-blind, placebo-controlled trial of 576 patients between the ages of 20-79, according to an FDA release. Patients received treatment for 52 weeks, with some receiving treatment for up to 100 weeks. 

Efficacy was measured by the forced vital capacity–the amount of air that can be forcibly exhaled form the lungs after taking the deepest breath possible. Those that took Ofeb had less lung function decline compared to those on the placebo, according to the FDA. 

Adverse reactions associated with the use of nintedanib include diarrhea, nausea, abdominal pain, vomiting, liver enzyme elevation, decreased appetite, headache, weight decreased, and hypertension. 

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