Boehringer Ingelheim presents new data on OFEV® (nintedanib) in idiopathic pulmonary fibrosis (IPF)

www.us.boehringer-ingelheim.comMay 16 2016

New analyses presented at the American Thoracic Society’s 2016 annual conference (ATS 2016) further add to the efficacy and safety profile of OFEV® (nintedanib) in idiopathic pulmonary fibrosis (IPF). In total, Boehringer Ingelheim presented 12 IPF-related abstracts at ATS, including further analyses of the INPULSIS trials, which add to the growing body of evidence reinforcing the clinical benefit of OFEV across a range of patients by showing that:

• OFEV slowed disease progression in a composite endpoint of lung function decline (forced vital capacity, or FVC, decrease ≥10%) and death.
• OFEV slowed lung function decline independent of disease severity as measured by GAP stage (patient’s gender, age or disease physiology) at baseline.
• OFEV significantly reduced the risk of a first investigator-reported acute exacerbation (reported as a serious adverse event) by 43% versus placebo based on pooled data from the INPULSIS trials.
• One-year data from post-marketing surveillance, including real-world clinical data from 6,700 patients taking OFEV, further confirmed the safety and tolerability profile seen in studies.

“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:

• OFEV significantly reduced the risk of disease progression by 40% (27.1%, OFEV vs. 41.4%, placebo; p<0.0001), as measured by a composite endpoint of worsening in lung function (absolute decline in FVC ≥10%) or death over 52 weeks. Furthermore, the analyses showed there was a consistent reduction in disease progression across a range of patients defined by baseline FVC. See full abstract.
• OFEV’s clinical benefit was consistent across subgroups. OFEV slowed the decline in lung function regardless of the patient’s GAP stage (gender, age and disease physiology) at baseline. See full abstract.
• OFEV significantly reduced the risk for time to first acute exacerbations reported by investigators as serious adverse events by 43% (3.6%, OFEV vs. 6.1%, placebo; p=0.0476) and 70% (1.6%, OFEV vs. 5%, placebo; p=0.0019) for serious adverse events adjudicated as confirmed or suspected acute exacerbations. Acute exacerbations reported as serious adverse events were associated with a higher risk of death than acute exacerbations reported as non-serious adverse events. See full abstract.
• One-year data on adverse events collected from more than 6,700 U.S. OFEV patients from post-marketing surveillance, including real-world clinical data, was consistent with those seen in the pivotal clinical trials. No new safety concerns or unexpected safety signals were observed. See full abstract.

“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 trials

INPULSIS-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:

• liver problems
• heart problems
• a history of blood clots
• a bleeding problem or a family history of a bleeding problem
• had recent surgery in your stomach (abdominal) area
• are a smoker. You should stop smoking prior to taking OFEV and avoid smoking during treatment.
• have any other medical conditions.

Tell your doctor if you:

• are pregnant or plan to become pregnant.
• are breastfeeding or plan to breastfeed. It is not known if OFEV passes into your breast milk. You and your doctor should decide if you will take OFEV or breastfeed. You should not do both.

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:

• Liver problems. Call your doctor right away if you have unexplained symptoms such as yellowing of your skin or the white part of your eyes (jaundice), dark or brown (tea colored) urine, pain on the upper right side of your stomach area (abdomen), bleeding or bruising more easily than normal or feeling tired. Your doctor will do blood tests regularly to check how well your liver function is working during your treatment with OFEV.
• Diarrhea, nausea, and vomiting. Tell your doctor if you have these symptoms or if they do not go away or become worse and if you are taking over-the-counter laxatives, stool softeners, and other medicines or dietary supplements that can cause diarrhea.  While you are taking OFEV, your doctor may recommend that you drink fluids or take medicine to treat these side effects.
• Heart attack. Tell your doctor right away if you have symptoms of a heart problem which may include chest pain or pressure, pain in your arms, back, neck or jaw, or shortness of breath.
• Stroke. Tell your doctor right away if you have symptoms of a stroke which may include numbness or weakness on 1 side of your body, trouble talking, headache, or dizziness.
• Bleeding problems.  OFEV may increase your chances of having bleeding problems.  Tell your doctor if you have unusual bleeding, bruising, or wounds that do not heal. Tell your doctor if you are taking a blood thinner, including prescription blood thinners and over-the-counter aspirin.
• Tear in your stomach or intestinal wall (perforation). OFEV may increase your chances of having a tear in your stomach or intestinal wall.  Tell your doctor if you have pain or swelling in your stomach area.

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 Ingelheim

Boehringer 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.