IPF patients treated with Ofev^® (nintedanib) versus placebo were twice as likely to have improved or stable lung function

Ridgefield, Conn., May 24, 2017 – Boehringer Ingelheim Pharmaceuticals, Inc. today announced the presentation of new analyses on the use of Ofev^® (nintedanib) in treating idiopathic pulmonary fibrosis (IPF) at the 2017 American Thoracic Society (ATS) conference. Abstracts presented at the conference support the established efficacy and safety data for Ofev and offer further insights into its effect on lung function in IPF patients.

Pooled data from the two Phase III INPULSIS^® trials showed that Ofev-treated patients were twice as likely as those given placebo to experience an improvement or no decline in lung function, as measured by forced vital capacity (FVC), at week 52 (36.8%, Ofev vs. 18.0%, placebo). A subgroup analysis of the open-label INPULSIS^®-ON study demonstrated a similar annual rate of FVC decline over 96 weeks among Ofev-treated patients, regardless of the dosage they received based on individual tolerability (150 mg twice daily, 100 mg twice daily, or both doses).

Additionally, a pooled analysis from the TOMORROW^™, and INPULSIS^® trials assessed the incidence rates for major adverse cardiovascular events (MACE) among patients treated with Ofev and placebo. Most patients included in this analysis (90%) had a high cardiovascular (CV) risk at baseline, including a history of fatty-plaque build-up in the arteries (called atherosclerosis) and/or at least one CV risk factor such as high blood pressure, diabetes or elevated blood cholesterol levels. Overall, the incidence of MACE was similar between the treatment groups both in patients with a high CV risk (3.5%, Ofev vs. 3.3%, placebo) and low CV risk (4.5%, Ofev vs. 5.3%, placebo) at baseline.

“IPF is a progressive disease that requires ongoing treatment. So, it is important to assess the long-term efficacy and safety of IPF treatments like Ofev to ensure we are maintaining lung function and reducing disease progression while not exacerbating co-existing conditions,” said Imre Noth, M.D., professor of medicine and director of the Interstitial Lung Disease Program at the University of Chicago. “These new data help to further strengthen the science supporting the efficacy and safety of Ofev for up to 96 weeks of treatment, and offer physicians additional evidence to support their treatment decisions.”

New Insights about IPF Patients
A separate analysis presented at ATS examined data from the IPF-PRO patient registry at 18 pulmonary care sites to identify the clinical characteristics of IPF patients who have advanced lung function impairment. Most clinical studies have included IPF patients with mild to moderate lung function impairment, and investigators wanted to understand how patients with more advanced disease differed. Patients with advanced IPF at baseline had greater physical impairment versus patients with mild to moderate disease, including lower six-minute walk distance (320 feet vs. 397 feet). The more advanced IPF patients also had an increased prevalence of hypoxemia (low blood oxygen), both at rest (36.6% vs. 7.4%) and while active (62.4% vs. 20.2%), requiring more supplemental oxygen, as well as a history of pulmonary arterial hypertension, or high blood pressure in the lungs (14.0% vs. 6.4%). In addition, health-related quality of life (HRQL) scores were significantly worse in those with advanced lung function impairment.

“At Boehringer Ingelheim, we are committed to IPF and broader ILD research and advancements to better understand these devastating diseases,” said Thomas Leonard, Ph.D., executive director, Clinical Development and Medical Affairs, Specialty Care, Boehringer Ingelheim Pharmaceuticals, Inc. “Through ongoing research, we are able to provide the IPF community with the information they need to make informed treatment decisions.”

Ongoing research is being conducted for the treatment of Ofev in patients with 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 is completed and will add evidence to the safety and tolerability of nintedanib in combination with pirfenidone. Results from the 12-week, randomized INJOURNEY trial will be presented at an upcoming international medical congress.

The corresponding abstracts can be found within the online program, here:
https://cms.psav.com/ats2017/confcal

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. 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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