Boehringer Ingelheim Presents New Data and Analyses Reinforcing the Safety and Efficacy of OFEV® (nintedanib) Capsules

RIDGEFIELD, Conn., May 18, 2015 /PRNewswire/ -- Boehringer Ingelheim announced new data and analyses that provide further evidence to support the efficacy, safety and tolerability of OFEV® (nintedanib) capsules in patients with idiopathic pulmonary fibrosis (IPF). The findings were presented yesterday at the American Thoracic Society 2015 International Conference in Denver.

"The long-term safety studies are important because people with IPF may be on therapy for an extended period," said lead study author Luca Richeldi, M.D., Ph.D., Professor of Respiratory Medicine, Chair of Interstitial Lung Disease, University of Southampton, Honorary Consultant Physician, University Hospital Southampton. "Additionally, results from other analyses show a consistent effect in patients who had mild lung function impairment or lacked extensive lung scarring, such as honeycombing in high-resolution CT scans. These new findings underscore the need for early detection and treatment."

IPF is a rare and serious lung disease that causes permanent scarring of the lungs. It affects as many as 132,000 Americans, most commonly men over the age of 65. Early diagnosis and proper care and treatment are critical to helping people with their condition. 

"Boehringer Ingelheim continues to research the safety and efficacy of OFEV to improve the understanding of IPF and the role that medicine can play in treating it," said Danny McBryan, M.D., vice president, Clinical Development and Medical Affairs, Respiratory, Boehringer Ingelheim Pharmaceuticals, Inc. "The data being presented at the American Thoracic Society International Conference provide additional insights into OFEV, including the safety and efficacy beyond 52 weeks. Data also look at the effect of OFEV treatment on patients with mild lung function impairment and characteristics consistent with early disease presentation, which is representative of those seen in clinical practice."

Additional details on the OFEV presentations are available here by searching the abstract numbers listed below.

Research Evaluating OFEV Beyond 52 Weeks

New Data and Interim Analyses of Phase III Trials Open-Label Safety Extension

The research presentations include an interim analysis of an open-label extension of the 52-week Phase III INPULSIS® trials (NCT01619085; abstract A1020). The results showed no relevant changes in the safety and tolerability profile of OFEV 150 mg twice daily in patients taking OFEV for nearly two years on average (12 months INPULSIS® study + 11 months in open-label safety extension). The open-label extension included patients who either continued on or initiated OFEV therapy following the 52-week trial period (AE: 88.8% vs. 93.8%, respectively; SAE: 31.9% vs. 29.6%, respectively).

New Data and Analyses of Phase II Trial Extension

Researchers also presented data from an extension of the Phase II TOMORROW® trial (NCT01170065; abstract A1019). Following the placebo-controlled phase of the trial (period 1: 52 weeks), patients were given the option to enter a second phase (period 2: 24 weeks). In this extension, patients in the treatment group (OFEV 150 mg twice daily, n=48) were given the option of continuing therapy, while patients in the placebo group were given the option of initiating treatment with OFEV 50 mg once daily in a comparator group (a sub-therapeutic dose, n=54).

Overall, the extension study showed:

• The absolute change in forced vital capacity (FVC, or the amount of air that can be exhaled after maximum inhalation), a measure of IPF disease progression, was lower in the treatment group (n=36) than in the comparator group (n=44) (-3.1% vs. -6.3%).
• The incidence of acute exacerbations (a sudden and serious attack of shortness of breath) was lower in the treatment group (n=86) versus the comparator group (n=87) (3.2 vs. 13.4 events for every 100 patient-years)
• Overall, adverse event (AE) and serious adverse event (SAE) rates across periods 1 and 2 for the two groups (n=85 per group) were similar (AE: 97.6% vs. 96.5%, respectively; SAE: 35.3% vs. 37.6%, respectively).

Phase III Trials Pooled Subgroup Analyses

Researchers also presented two post-hoc subgroup analyses from pooled results of the Phase III INPULSIS® trials.

Disease Progression Based on Diagnostic Criteria

In the first post-hoc analysis (NCT01335464 and NCT01335477; abstract A1022), OFEV showed a consistent effect on annual rate of FVC decline, a measure of disease progression, whether or not patients had signs of honeycombing in a lung imaging test and/or a diagnosis confirmed by biopsy provided that they met other diagnostic imaging criteria required for trial participation. The adjusted annual rates of decline in FVC compared to placebo were as follows:

• Patients with honeycombing and/or biopsy: difference 117.0 mL/year (nintedanib (n=425) -108.7 ml/year vs. placebo (n=298) -225.7 ml/year)   
• Patients with no honeycombing or biopsy: difference 98.9 mL/year (nintedanib (n=213) -122.0 ml/year vs. placebo (n=125) -221.0 ml/year)

Disease Progression in Patients with Varying Degrees of Lung Function Impairment

In the second analysis (NCT01335464 and NCT01335477; abstract A1021), OFEV showed a consistent effect on annual rate of FVC decline, a measure of disease progression, whether patients had a baseline FVC of </= 90% predicted or > 90% predicted.

• Patients with baseline FVC>90% predicted, difference: 133.1 mL/year (nintedanib (n=166) -91.5 mL/year vs. placebo (n=108) -224.6 mL/year)
• Patients with baseline FVC</=90% predicted, difference: 102.1 mL/year (nintedanib (n=472) -121.5 mL/year vs. placebo (n=315) -223.6 mL/year)

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 the Phase II TOMORROW™ trial (NCT00514683) and the Phase III INPULSIS™ trials (INPULSIS™-1 and INPULSIS™-2; NCT01335464 and NCT01335477) which were all 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.

IMPORTANT SAFETY INFORMATION

WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT OFEV (NINTEDANIB)?
OFEV can cause birth defects or death to an unborn baby. Women should not become pregnant while taking OFEV. Women who are able to become pregnant should use birth control during treatment and for at least 3 months after treatment. If you become pregnant while taking OFEV, tell your doctor right away.

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 diarrhea, nausea, or vomiting or if these symptoms do not go away or become worse. Tell your doctor 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. These symptoms 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. These symptoms 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.

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, or have any other medical conditions.

Tell your doctor if you are pregnant or plan to become pregnant. You should avoid becoming pregnant while taking OFEV. OFEV can cause harm, birth defects or death to your unborn baby. Use appropriate birth control methods while taking OFEV and for at least 3 months after your last dose. Tell your doctor if you 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 if you currently smoke. You should stop smoking prior to taking OFEV and avoid smoking during treatment.

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.

Click here for full Prescribing Information, including Patient Information.

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.

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 146 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 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 2014, Boehringer Ingelheim achieved net sales of about $16.96 billion dollars (13.3 billion euros). R&D expenditure corresponds to 19.9 percent of its net sales.

For more information please visit www.us.boehringer-ingelheim.com, or follow us on Twitter @BoehringerUS.  

SOURCE Boehringer Ingelheim

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