New analysis supports long-term treatment with Ofev® in SSc-ILD patients

• An interim analysis of the long-term safety of Ofev® (nintedanib) supports existing evidence for use in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD)
• The safety profile of Ofev was consistent with the Phase III SENSCIS® trial, according to the analysis
• The analysis also showed a reduction in lung function decline with use of Ofev in SSc-ILD patients, as measured by forced vital capacity (FVC)

RIDGEFIELD, Conn., Nov. 5, 2020 /PRNewswire/ -- Boehringer Ingelheim today announced results from an interim analysis of the SENSCIS®-ON trial evaluating Ofev® (nintedanib) in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD). The new analysis was published online as part of ACR Convergence 2020.

SENSCIS-ON is an open-label extension trial to assess the long-term tolerability and safety of Ofev in patients with SSc-ILD who completed the Phase III SENSCIS® trial. The study also evaluated the change from baseline in forced vital capacity (FVC) as a measure of lung function over 52 weeks.

The interim analysis showed that the safety profile of Ofev in SENSCIS-ON was consistent with that reported over 52 weeks in the SENSCIS trial with diarrhea being the most frequently reported adverse event. The analysis showed that 347 patients in the extension study who received Ofev demonstrated a decrease in FVC over 52 weeks as did patients in the SENSCIS study. The average change in FVC from baseline to week 52 of SENSCIS-ON was −51.3 mL in all patients treated in SENSCIS-ON, while the change from baseline to week 52 in the SENSCIS trial was −42.7 mL.

"With this new analysis, we now have data following patients for two years showing the impact of Ofev in reducing lung function decline and a consistent safety profile in patients with SSc-ILD," commented Thomas Leonard, Ph.D., executive director, Clinical Development and Medical Affairs, Specialty Care IPF/ILD, Boehringer Ingelheim Pharmaceuticals, Inc. "These new data add to the important body of evidence for Ofev and the role it plays for patients with SSc-ILD."

Health system database analysis
Four to six percent of patients presented with ILD a year prior to their SSc diagnosis, as reported in a retrospective study of more than 2,800 patients in a large health insurance system.

"These findings confirm that interstitial lung disease can present early in the course of SSc," said Shervin Assassi, M.D., director, Division of Rheumatology, The University of Texas, Houston. "These data are consistent with other studies and reinforce the need to examine SSc patients early for pulmonary involvement."

About SSc-ILD
Systemic sclerosis, also known as scleroderma, is a rare autoimmune disease characterized by thickening and scarring of connective tissue throughout the body. The disease is estimated to affect about 100,000 people in the U.S. and 2.5 million worldwide. Fibrosis, the hallmark of the disease, can affect the skin and internal organs, including the lungs. Interstitial lung disease (ILD), one of the most frequent disease manifestations, can be debilitating and may become life-threatening. Approximately 25 percent of patients develop significant lung involvement within three years of diagnosis. ILD is the leading cause of death among people with SSc.

About Ofev
Ofev is already approved in the U.S. and more than 80 countries for the treatment of patients living with IPF. In September 2019, Ofev was approved in the U.S. as the first and only therapy to slow the rate of decline in pulmonary function in patients with SSc-ILD, and then in March 2020 to treat patients with chronic fibrosing ILDs with a progressive phenotype.

What is OFEV?

• OFEV is a prescription medicine used:
  • to treat people with a lung disease called idiopathic pulmonary fibrosis (IPF).
  • to treat people with a chronic (long lasting) interstitial lung disease in which lung fibrosis continues to worsen (progress).
  • to slow the rate of decline in lung function in people with systemic sclerosis-associated interstitial lung disease (SSc-ILD) (also known as scleroderma-associated ILD).
• 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?

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 highly effective birth control at the start of treatment, during treatment, and for at least 3 months after your last dose. Talk with your doctor about what birth control method is right for you during this time. Birth control pills may not work as well in women having vomiting, diarrhea, or other problems reducing the drug absorption. If you have any of these problems, talk with your doctor about what highly effective birth control method is right for you. If you become pregnant or think you are 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 about all of your medical conditions, including 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.

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, and 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, feeling tired, or loss of appetite. Your doctor will do blood tests to check how well your liver is working before starting and 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 one 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, 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.

Please see full Prescribing Information, including Patient Information.

CL-OF-100044 10.28.2020

About Boehringer Ingelheim
Making new and better medicines for humans and animals is at the heart of what we do. Our mission is to create breakthrough therapies that change lives. Since its founding in 1885, Boehringer Ingelheim is independent and family-owned. We have the freedom to pursue our long-term vision, looking ahead to identify the health challenges of the future and targeting those areas of need where we can do the most good.

As a world-leading, research-driven pharmaceutical company, more than 51,000 employees create value through innovation daily for our three business areas: Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing. In 2019, Boehringer Ingelheim achieved net sales of around $21.3 billion (19 billion euros). Our significant investment of over $3.9 billion (3.5 billion euros) in R&D drives innovation, enabling the next generation of medicines that save lives and improve quality of life.

We realize more scientific opportunities by embracing the power of partnership and diversity of experts across the life-science community. By working together, we accelerate the delivery of the next medical breakthrough that will transform the lives of patients now, and in generations to come.

Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation and is part of the Boehringer Ingelheim group of companies. In addition, there are Boehringer Ingelheim Animal Health in Duluth, GA and Boehringer Ingelheim Fremont, Inc. in Fremont, CA.

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