Ofev® demonstrates consistent long-term efficacy in IPF regardless of baseline lung function

Ridgefield, Conn., October 23, 2017 – Boehringer Ingelheim announced today the presentation of a new analysis on the use of Ofev® (nintedanib) in treating people with idiopathic pulmonary fibrosis (IPF) at the 2017 CHEST Annual Meeting.

Results from an open-label extension of the Phase III INPULSIS® trial, known as INPULSIS®-ON, suggest Ofev is effective in slowing IPF disease progression regardless of lung function at the start of treatment. Ofev demonstrated a consistent slowing in the annual rate of decline in lung function, as measured by forced vital capacity (FVC), over 96 weeks regardless of baseline FVC. Specifically:

• Among patients with FVC≤ 90% and FVC >90% predicted at baseline, the adjusted annual rates of decline in lung function over 96 weeks were -125.8 mL/year and -98.7 ml/year, respectively.
• Similarly, among patients with FVC ≤70% and FVC ≥70% predicted at baseline, the adjusted annual rates of decline in lung function over 96 weeks were -132.9 mL/year and -109.1 ml/year, respectively.

Additionally, the adjusted annual rate of lung function decline at 96 weeks among all participants in the INPULSIS-ON trial was comparable to the rate of decline observed at 52 weeks in the Phase III INPULSIS trials (-117.8 mL/year and -113.6 mL/year, respectively) in the nintedanib-treated arms.

“Baseline lung function and changes in FVC over time are both important predictors of long-term outcomes in IPF, so it is critical to maintain lung function across disease severities,” said Mitchell Kaye, M.D., president of Minnesota Lung Center/Minnesota Sleep Institute, Minneapolis. “These new results provide further supportive evidence for the long-term efficacy of Ofev, suggesting the value of initiating IPF treatment irrespective of a person's disease severity at diagnosis.”

Characteristics of people with IPF compared to those enrolled in clinical trials
A second abstract presented at CHEST explored data from the IPF-PRO Registry of people with IPF at 18 pulmonary care sites that compared their characteristics in a real-world setting to those eligible to participate in clinical trials. The analysis examined inclusion criteria from two IPF trials:

• INPULSIS: Diagnosis within the past five years, age ≥40 years, FVC ≥50% predicted, DLco values (diffusing of the lungs or carbon monoxide) between 30% and 79% predicted.
• ASCEND: Diagnosis within the past four years, age of 40-80 years, FVC between 50% and 90% predicted, and DLco between 30% and 90% predicted.

The data showed similarities between people in the IPF-PRO Registry and the two populations in the clinical trials. Specifically, of the 419 people analyzed, all met the inclusion criteria for time of diagnosis in the two IPF trials. All participants were aged ≥40 years and 92.8% were 40-80 years. Among people with available FVC values at enrollment (n=371), 90.3% had FVC ≥50% predicted and 76.5% had FVC between 50% and 90% predicted. For participants with DLco values (n=360), 78.1% had values between 40% and 79% predicted and 78.6% had values between 30% and 90% predicted.

“Boehringer Ingelheim is continually focused on better understanding IPF and identifying prescribing patterns and treatment outcomes in real-world settings,” said Thomas Leonard, Ph.D., executive director, Clinical Development and Medical Affairs, Specialty Care, Boehringer Ingelheim. “The knowledge we are unlocking through the ongoing IPF-PRO Registry underscores this commitment and will help us improve the care of those living with this disease.”

Ongoing research is being conducted for the use of nintedanib in treating IPF and other interstitial lung diseases. Nintedanib is also being investigated for the treatment of systemic sclerosis with associated interstitial lung disease (SSc-ILD), as well as progressive fibrosing interstitial lung disease (PF-ILD). Additionally, the first Phase IV trial following the approval of Ofev for the treatment of IPF has been completed and results from the 12-week, randomized INJOURNEY trial have been published in the American Journal of Respiratory and Critical Care Medicine, here.

The corresponding abstracts can be found within the online program, here: http://journal.chestnet.org/meetings

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. Patients who completed the 52-week treatment period and a 4-week follow-up period in the INPULSIS® trials were offered open-label treatment with Ofev® as part of an extension trial to assess the long-term safety and tolerability of Ofev.

About the INPULSIS®-ON open label extension trial
Patients who completed the 52-week treatment period and a 4-week follow-up period in the INPULSIS® trials were invited to receive open-label treatment with nintedanib* as part of an extension trial to assess the long-term safety and tolerability of nintedanib*. The INPULSIS®-ON (Clinicaltrial.gov trial identifier: NCT01619085) trial included 734 patients and is currently ongoing.

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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