Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) approved OFEV® (nintedanib) capsules for oral use for the treatment of idiopathic pulmonary fibrosis (IPF). Granted Breakthrough Therapy designation during its review by the FDA, OFEV, capsules for oral use, taken twice daily, is the only kinase inhibitor approved to treat IPF. OFEV will be available to patients within 10 days.
IPF is a rare and fatal lung disease that affects as many as 132,000 Americans. Most people with IPF only live three to five years after diagnosis. IPF typically affects men over the age of 65.
"While the cause of IPF is unknown and there is no known curative treatment, the unfortunate patients confronted with the disease and physicians caring for patients in the U.S. have been anxiously awaiting FDA-approved treatments," said Ganesh Raghu, M.D., Professor of Medicine, University of Washington in the Division of Pulmonary and Critical Care Medicine and Director of Center for Interstitial Lung Diseases at University of Washington Medical Center, Seattle, WA. "In three clinical trials, nintedanib slowed lung function decline compared to placebo. This approval is a welcome development for patients and caregivers and it provides hope for those who are living with this devastating disease."
Decline in lung function, the primary endpoint, was measured by Forced Vital Capacity (FVC in mL) over one year (annual rate of decline) versus placebo. FVC is the volume of air that can be forcibly exhaled after full inhalation.
In research, Boehringer Ingelheim discovered that nintedanib, a kinase inhibitor, blocks growth factor receptors implicated in IPF – including the vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor receptor (FGFR) and platelet-derived growth factor receptor (PDGFR).
"This approval is a major milestone in IPF with OFEV demonstrating a significant impact on the slowing of lung function decline and a significant reduction in the risk of a first acute exacerbation of IPF over 52 weeks," said Tunde Otulana, M.D., a pulmonologist and senior vice president, Clinical Development and Medical Affairs at Boehringer Ingelheim. "As a research-driven pharmaceutical company, moments like these, when we can bring a treatment option to patients who are very much in need, makes us extremely proud and inspires us to continue our quest for effective therapies to positively impact patients' lives."
To support people living with IPF who will be prescribed OFEV, Boehringer Ingelheim has developed OPEN DOORS™ – a comprehensive patient support program that will provide a broad range of financial and nursing support services. Accessible through www.OFEV.com and at 1-866-673-6366, OPEN DOORS™ services and resources include:
- Access to nurse support 24 hours a day, 7 days a week
- Assistance in finding financial resources to support access to OFEV
- Access to information about IPF and assistance in identifying local resources, such as support groups
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