Efficacy and Safety of Ofev (Nintedanib) as IPF Treatment Supported by New Analyses

Efficacy and Safety of Ofev (Nintedanib) as IPF Treatment Supported by New Analyses

Boehringer Ingelheim Pharmaceuticals presented 12 idiopathic pulmonary fibrosis (IPF)-related abstracts at the recent American Thoracic Society (ATS) 2016 Annual Conference, including further analyses of its INPULSIS clinical trial program, which added to the growing body of evidence supporting the clinical benefits of Ofev (nintedanib) to treat IPF.

“Boehringer Ingelheim is committed to furthering science that addresses the unmet needs of people with rare diseases where limited treatments exist,”  Danny McBryan, MD, the company’s vice president of Clinical Development and Medical Affairs, Respiratory, said in a press release.  “Already, more than 10,000 patients worldwide have received treatment with OFEV to date, and we’re continually working to advance the understanding of IPF through our clinical trial program and ongoing research of OFEV in the real-world clinical setting.”

INPULSIS-1 and INPULSIS-2 are Boehringer-led, global Phase 3 clinical trials that evaluated the efficacy and safety of nintedanib in the treatment of IPF. The trials’ design was identical (matching dosing, inclusion criteria and endpoints) with a similar range in patient types — similar to those seen in clinical practice, including patients with early disease, no honeycombing on HRCT, a type of computed tomography, and/or concomitant emphysema.

Data from the new analyses showed:

  • Ofev significantly reduced disease progression by 40%, as measured by a composite endpoint of lung function decline (a forced vital capacity (FVC) decrease greater than or equal to 10%) (read abstract);
  • Ofev slowed lung function decline regardless of disease severity, as measured by GAP stage (patients’ gender, age or disease physiology) at baseline (read abstract);
  • Ofev significantly reduced the risk of a first investigator-reported acute exacerbation (described as a serious adverse event) by 43% versus placebo (read abstract);
  • Further evidence of Ofev’s safety and tolerability, with one-year data from post-marketing surveillance in 6,700 patients using the drug, including real-world clinical data, confirming results reported in studies (read abstract).

“IPF progression is variable and unpredictable, but, over time, the lung function of patients gradually and irreversibly declines,” said Imre Noth, MD, a University of Chicago professor of Medicine and director of the Interstitial Lung Disease Program. “Ongoing analyses of the Phase III INPULSIS trials along with real-world data provide additional support for the safety and efficacy of treatment with OFEV. As slowing disease progression is an important treatment goal, these data provide support for the benefit of IPF patients regardless of disease severity.”

Ofev, a small molecule tyrosine kinase inhibitor, is approved by both the U.S. Food and Drug Administration (FDA) and the European Commission for IPF.

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