Efficacy and Safety of Nintedanib (Ofev), an IPF Drug, Confirmed in New Analyses of Phase 3 Trials

New analyses, presented at the American Thoracic Society (ATS) 2016 Annual Conference, further support the efficacy and safety of nintedanib (Ofev) in treating idiopathic pulmonary fibrosis (IPF). Boehringer Ingelheim shared a host of data at the meeting, establishing nintedanib as an important player in IPF management, irrespective of disease severity.

“IPF progression is variable and unpredictable, but, over time, the lung function of patients gradually and irreversibly declines,” Imre Noth, a professor of Medicine and director of the Interstitial Lung Disease Program at the University of Chicago, said in a press release. “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.”

Data presented across 12 IPF-related abstracts included new information from the two INPULSIS trials, both evaluating nintedanib in a mixed patient population, including patients at early disease stages with no evidence of honeycombing detected by high-resolution computed tomography or emphysema.

Nintedanib treatment was shown to decrease the risk of disease progression by 40 percent — measured by changes in lung function decline or death — in all groups of patients, irrespective of gender, age, and disease physiology. The drug also reduced the risk for time to first acute exacerbations by 43 percent across both trials, reported as serious adverse events by trial investigators.

Real-life clinical data, involving 6,700 patients, collected over one year in a post-marketing surveillance program, also confirmed the safety of nintedanib, which was on par with what has been shown previously in clinical trials.

“Boehringer Ingelheim is committed to furthering science that addresses the unmet needs of people with rare diseases where limited treatments exist,” said Danny McBryan, MD, vice president, Clinical Development and Medical Affairs, Respiratory, Boehringer Ingelheim Pharmaceuticals, Inc. “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.”

Nintedanib (Ofev), a kinase inhibitor designed to block multiple pathways thought to be involved in the scarring of lung tissue, was approved by the U.S. Food and Drug Administration (FDA) to treat IPF in October 2014.