RIDGEFIELD, Conn., May 16, 2016 /PRNewswire/ -- New analyses presented at the American Thoracic Society's 2016 annual
"IPF progression is variable and unpredictable, but, over time, the lung function of patients gradually and irreversibly declines," said Imre Noth, M.D., Professor of Medicine and Director of the Interstitial Lung Disease Program at the University of Chicago. "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."
The new analyses from the pooled Phase III INPULSIS trials showed that:
"Boehringer Ingelheim is committed to furthering science that addresses the unmet needs of people with rare diseases where limited treatments exist," said Danny McBryan, M.D., 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."
About Idiopathic Pulmonary Fibrosis (IPF)IPF is a rare and serious lung disease that causes permanent scarring of the lungs. It affects as many as 132,000 Americans, typically men over the age of 65. Early diagnosis and proper care are critical to helping people treat their condition.
About the INPULSIS trialsINPULSIS-1 and -2 are two global Phase III trials which evaluated the efficacy and safety of nintedanib in the treatment of idiopathic pulmonary fibrosis (IPF).
The INPULSIS trials were identical in design, e.g., with matching dosing, inclusion criteria and endpoints. INPULSIS recruited a range of patient types – similar to those seen in clinical practice including patients with early disease (FVC > 90% pred), no honeycombing on HRCT and/or concomitant emphysema.
About OFEV® (nintedanib) capsules The U.S. Food and Drug Administration (FDA) approved OFEV for the treatment of idiopathic pulmonary fibrosis (IPF) on October 15, 2014. OFEV is one of the first FDA-approved drug treatments for IPF and the only kinase inhibitor approved to treat this disease.
The approval was based on findings from a robust clinical trial program involving more than 1,200 patients with IPF worldwide, and included the Phase II TOMORROW™ trial (NCT00514683) and the Phase III INPULSIS™ trials (INPULSIS™-1 and INPULSIS™-2; NCT01335464 and NCT01335477). All these studies were randomized, double-blind, placebo-controlled trials comparing OFEV 150 mg twice daily to placebo for 52 weeks. Both INPULSIS™ trials were identically designed while the TOMORROW™ study design was similar.
What is OFEV?OFEV is a prescription medicine used to treat people with a lung disease called idiopathic pulmonary fibrosis (IPF). It is not known if OFEV is safe and effective in children.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about OFEV (nintedanib)?
OFEV can cause harm, birth defects or death to an unborn baby. Women should not become pregnant while taking OFEV and should use birth control during and for at least 3 months after your last dose. If you become pregnant while taking OFEV, tell your doctor right away.
What should I tell my doctor before using OFEV?
Before you take OFEV, tell your doctor if you have:
Tell your doctor if you:
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements such as St. John's wort. Keep a list of the medicines you take and show it to your doctor and pharmacist when you get a new medicine.
What are the possible side effects of OFEV?
OFEV may cause serious side effects, including:
The most common side effects of OFEV are diarrhea, nausea, stomach pain, vomiting, liver problems, decreased appetite, headache, weight loss, and high blood pressure.
These are not all the possible side effects of OFEV. For more information, ask your doctor or pharmacist. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Click here for full Prescribing Information, including Patient Information.
Boehringer IngelheimBoehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation.
Boehringer Ingelheim is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, the company operates globally with 145 affiliates and more than 47,000 employees. Since its founding in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel treatments for human and veterinary medicine.
Boehringer Ingelheim is committed to improving lives and providing valuable services and support to patients and their families. Our employees create and engage in programs that strengthen our communities. To learn more about how we make more health for more people, visit our Corporate Social Responsibility Report.
In 2015, Boehringer Ingelheim achieved net sales of about $15.8 billion (14.8 billion euros). R&D expenditure corresponds to 20.3 percent of its net sales.
For more information please visit www.us.boehringer-ingelheim.com, or follow us on Twitter @BoehringerUS.
Contact:Boehringer IngelheimPharmaceuticals, Inc.Name: Paul WynnPublic RelationsPhone: 203-798-4887Email: [email protected]
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/new-presentations-at-ats-2016-reinforce-ofev-nintedanib-efficacy-safety-and-tolerability-across-range-of-patients-with-ipf-300268604.html
SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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