The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to nintedanib (Ofev; Boehringer Ingelheim) for the treatment of chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype.

The designation is supported by data from the 52-week, double-blind, placebo-controlled, phase 3 INBUILD trial that evaluated the efficacy and safety of nintedanib in 663 patients with progressive fibrosing ILD (PF-ILD), defined as patients with diffuse fibrosing lung disease of >10% extent on high-resolution computed tomography. Patients were randomized to receive either nintedanib 150mg twice daily or placebo. The primary end point was the annual rate of decline in forced vital capacity (FVC).

Findings from the study demonstrated nintedanib slowed lung function decline by 57% in the overall study population with a statistically significant adjusted rate of decline in FVC of -80.8mL per year vs -187.8mL per year with placebo, for a difference of 107mL per year between treatment arms (95% CI, 65.4 to 148.5; P <.001). Specifically, in patients with a usual interstitial pneumonia-like (UIP) fibrotic pattern, the nintedanib group had an adjusted rate of decline in FVC of -82.9mL per year vs -211.1mL per year in the placebo group (treatment difference: 128.2mL [95% CI, 70.8 to 185.6; P <.001]).

Full study results were recently published on September 29, 2019 in the New England Journal of Medicine.


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Regarding safety, the most common treatment-emergent adverse event was diarrhea, reported in 66.9% and 23.9% of patients treated with nintedanib and placebo, respectively. The overall safety profile observed for nintedanib was consistent with previous studies.

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“We believe Ofev may help address an unmet medical need by providing a therapy for patients across a spectrum of ILDs with a progressive phenotype,” said Thomas Seck, MD, SVP, Medicine and Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. “We are encouraged by this Breakthrough Therapy Designation and look forward to working closely with the agency to offer this therapy to patients for which there are no FDA-approved treatment options.”

Ofev is already indicated for the treatment of idiopathic pulmonary fibrosis (IPF), and to slow the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD). It is supplied as 100mg and 150mg capsules in 60-count bottles.

For more information visit boehringer-ingelheim.us.