Results From Boehringer Ingelheim’s Six-Month Lung Imaging Study Showed Slowing of Fibrotic Progression in Patients With IPF Treated With Ofev Versus Placebo

RIDGEFIELD, Conn., Nov. 10, 2017 /PRNewswire/ -- Boehringer Ingelheim today announced results from a descriptive Phase IIIb lung imaging study providing evidence for the first time that Ofev^® (nintedanib) slowed the fibrotic process versus placebo in people with idiopathic pulmonary fibrosis (IPF). The results are being presented at the Pulmonary Fibrosis Foundation (PFF) Summit 2017, November 9-11 in Nashville, Tenn.

The study showed a reduction in the development of lung fibrosis among people treated with Ofev, as measured by quantitative lung fibrosis score (QLF), which uses high resolution CT (HRCT) imaging to measure the extent of lung fibrosis (thickening and scarring of the lungs). Lower QLF scores indicate less fibrotic progression in the lung. In this study, the QLF score from baseline to 6 months was 11.4% in people treated with Ofev versus 14.6% in the placebo group (difference 3.2%, exploratory endpoint not statistically significant).

“With the aid of high resolution CT scans, we have observed a reduction in the progression of lung fibrosis with Ofev versus placebo,” said lead study investigator Lisa Lancaster, M.D., clinical director of the Interstitial Lung Disease Program at Vanderbilt University Medical Center. “These encouraging results demonstrate that through an imaging scan we identified differential responses in fibrotic changes between groups that will help doctors make informed treatment decisions.”

Study Results
The primary endpoint of this randomized, double-blind, placebo-controlled, descriptive trial was change in relative QLF score from baseline to 6 months of treatment.

A secondary endpoint of the trial was absolute mean change in forced vital capacity (FVC), a measure of lung function. At baseline, mean FVC was 2997 (831) mL among people treated with Ofev and 2921 (834) mL among people on placebo. The adjusted mean absolute changes in FVC from baseline to month 6 were −14.2 mL and −83.2 mL in the Ofev and placebo groups, respectively (difference 69.0 mL).

“This study reaffirms the beneficial effect of Ofev for reducing lung function decline and slowing disease progression, and is the first to suggest that there may be a differential effect of Ofev treatment versus placebo in lung fibrosis change,” said Thomas Leonard, Ph.D., executive director, Clinical Development and Medical Affairs, Specialty Care, Boehringer Ingelheim. “We look forward to presenting additional findings from this study at major medical congresses next year and confirmation of these results in future studies.”

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 Ofev® (nintedanib)
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 and the Phase III INPULSIS^® trials (INPULSIS®-1 and INPULSIS^®-2). 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. Women who are able to become pregnant should have a pregnancy test before starting treatment 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
• 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 should not breastfeed while taking Ofev.
• are a smoker. 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, herbal supplements such as St. John’s wort.

What are the possible side effects of Ofev?

Ofev may cause serious side effects.

TELL YOUR DOCTOR RIGHT AWAY if you are experiencing any side effects, including:

• Liver problems. Unexplained symptoms may include 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 is working during your treatment with Ofev.
• Diarrhea, nausea, and vomiting. Your doctor may recommend that you drink fluids or take medicine to treat these side effects. Tell your doctor if you have these symptoms, if they do not go away, or get worse and if you are taking over-the-counter laxatives, stool softeners, and other medicines or dietary supplements.
• Heart attack. Symptoms of a heart problem may include chest pain or pressure, pain in your arms, back, neck or jaw, or shortness of breath.
• Stroke. Symptoms of a stroke 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 and/or 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.

About 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 top 20 pharmaceutical companies. Headquartered in Ingelheim, Germany, the company operates globally with approximately 50,000 employees. Since its founding in 1885, the company has remained family-owned and today creates value through innovation for three business areas including human pharmaceuticals, animal health and biopharmaceutical contract manufacturing.

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. Please visit our website to learn more about how we make more health for more people through our Corporate Social Responsibility initiatives.

In 2016, Boehringer Ingelheim achieved net sales of about $17.6 billion (15.9 billion euros). R&D expenditure corresponds to 19.6 percent of its net sales.

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

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