The Food and Drug Administration (FDA) has approved Ofev (nintedanib; Boehringer Ingelheim) capsules as the first FDA-approved treatment to slow the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD). 

The approval was based on results from the 52-week, randomized, double-blind, placebo-controlled phase 3 SENSCIS trial that evaluated the efficacy and safety of nintedanib in patients with systemic sclerosis and associated ILD (N=576). Results showed the annual rate of decline of forced vital capacity (FVC) over 52 weeks (primary end point) was significantly reduced by 41mL in patients receiving nintedanib compared with those receiving placebo, corresponding to a relative treatment effect of 44%. 

The absolute change from baseline in the modified Rodnan skin score at Week 52 was a key secondary endpoint, however no benefit was observed in patients receiving nintedanib. In addition, no difference in survival was observed in an exploratory analysis of mortality over the whole trial (additional secondary end point).

With regard to safety, the most common treatment-emergent adverse reactions were diarrhea, abdominal pain, vomiting, liver enzyme elevation, decreased appetite, headache, decreased weight, and hypertension.

“Patients suffering from scleroderma need effective therapies, and the FDA supports the efforts of drug companies that are designing and conducting the clinical trials necessary to bring treatment options to scleroderma patients,” said Nikolay Nikolov, MD, associate director for Rheumatology of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research. “Nintedanib is now a treatment option to slow the rate of decline in pulmonary function in patients who have interstitial lung disease from scleroderma.”

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Ofev, a kinase inhibitor, is also indicated for the treatment of idiopathic pulmonary fibrosis. It is supplied as 100mg and 150mg capsules in 60-count bottles.

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