Boehringer Ingelheim recently announced new positive data on the company’s FDA-approved therapy OFEV® (nintedanib) for the treatment of idiopathic pulmonary fibrosis (IPF). The results were presented at the Pulmonary Fibrosis Foundation’s PFF Summit 2015 in Washington, D.C.
OFEV is a tyrosine-kinase inhibitor (TKI) that targets growth factors, such as the vascular endothelial growth factor receptor (VEGFR), which have been shown to be potentially involved in IPF pathogenesis. OFEV was one of the first treatments approved by the U.S. Food and Drug Administration (FDA) on October, 2014 for IPF.
“The approval of OFEV® was supported by evidence from three well-designed studies part of a comprehensive clinical trial programme and it is key to continually analyse the real-world experiences of people on therapy given the limited data on IPF,” explained Dr. Imre Noth, Professor of Medicine and Director of the Interstitial Lung Disease Programme at The University of Chicago, in a Boehringer Ingelheim’s press release.
Researchers led by Dr. Noth have conducted a post-marketing surveillance analysis on OFEV’s safety and tolerability in the United States. They found that the safety profile of the drug was consistent to the one previously reported in the clinical trials that led to OFEV’s approval by the FDA. The side effect most frequently reported was diarrhea but also other gastrointestinal occurrences, such as nausea, vomiting, and decline in appetite were also reported.
“These first results from the post-marketing surveillance study, which showed a consistent safety profile of OFEV® as described in the prescribing information, are important because they provide healthcare providers with additional information when considering OFEV® for their patients with IPF,” noted Dr. Noth.
At the PFF Summit 2015, researchers also presented results from two separate post-hoc analyses of an open-label extension of the one-year Phase 3 clinical trial INPULSIS (NCT01619085) evaluating OFEV. In total, 734 individuals participated.
One of the analyses showed that regardless of the patients’ disease severity at the start of the study, a similar decline in lung function was observed in all patients analyzed. The second analysis revealed that OFEV was an effective therapy over the course of approximately two years (100 weeks), demonstrating the drug’s long-term effect in slowing lung function decline as a measure of disease progression.
“At Boehringer Ingelheim, we are committed to improving the understanding of IPF and the role that OFEV® plays in the treatment of this disease,” said Dr. Danny McBryan, vice president, Clinical Development and Medical Affairs, Respiratory, Boehringer Ingelheim Pharmaceuticals, Inc. “Collectively, these analyses support the suggestion that OFEV® continues to be effective out to approximately two years and that the decline in lung function is similar in people receiving OFEV® with severe or mild to moderate impairment of lung function. These results add to our understanding of OFEV® by providing insight into the impact over a longer period of time and in patients that were not included in the studies supporting its approval.”
The research team also presented a post-hoc analysis from the Phase 3 INPULSIS trials (NCT01335464 and NCT01335477) focused on patients who maintained their OFEV dose regimen and those who had to reduce it from 150 mg to 100 mg (twice daily) or interrupt the treatment due to side effects. Researchers showed that interruptions or OFEV dose reductions did not have a negative effect on the efficacy of the drug in IPF patients.