FDA approves Ofev® as the first and only therapy to slow the rate of decline in pulmonary function in patients with systemic sclerosis-associated ILD

RIDGEFIELD, Conn., Sept. 9, 2019 /PRNewswire/ -- Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) approved Ofev^® (nintedanib) as the first and only medicine to slow the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD). Ofev is already approved in the U.S. and more than 70 countries for the treatment of patients living with idiopathic pulmonary fibrosis (IPF), and has been shown to slow IPF progression by reducing the annual rate of decline in lung function, as measured by forced vital capacity (FVC).

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"This is the first FDA-approved therapy to slow the rate of decline in pulmonary function for systemic sclerosis-associated interstitial lung disease and provides hope to patients and their loved ones facing this devastating disease," said Thomas Seck, M.D., senior vice president, Medicine & Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "This approval is supported by positive evidence from the Phase III study that showed Ofev significantly slowed the progression of lung function decline in this patient population and exemplifies Boehringer Ingelheim's dedication to the rare disease community."

Largest SSc-ILD study to date
The approval was based on results of SENSCIS^®, a Phase III double-blind randomized, placebo-controlled trial, that involved 576 patients from 194 trial sites across 32 countries. The primary endpoint was the annual rate of decline in FVC in patients with SSc-ILD. Results show that Ofev slowed the loss of pulmonary function by 44% (41 mL/year) in patients with SSc-ILD relative to placebo, as measured by FVC over 52 weeks.

The safety and tolerability of Ofev were evaluated in SSc-ILD patients. The most common adverse reactions (occurring in greater than or equal to 5%) in Ofev-treated patients compared to placebo included: diarrhea, nausea, vomiting, skin ulcer, abdominal pain, liver enzyme elevation, weight decreased, fatigue, decreased appetite, headache, fever, back pain, dizziness and hypertension. Please see additional Important Safety Information included below.

"An approved anti-fibrotic medication for this condition is a scientific advancement in the care of patients living with this rare disease," said Kristin Highland, M.D., pulmonologist with the Cleveland Clinic. "The option to offer a new therapy is welcome news for doctors and their patients."

About SSc-ILD
Systemic sclerosis (SSc), 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.

Advocacy community perspective
Robert Riggs, chief executive officer of the Scleroderma Foundation, who has observed stronger interest in scleroderma research in the past few years said: "This approval brings hope to a community in need of new options to treat scleroderma-associated ILD."

Luke Evnin, Ph.D., a scleroderma patient and chairman of the Scleroderma Research Foundation commented: "When interstitial lung disease occurs in systemic sclerosis, the consequences can be severe. The availability of a new therapy for patients with this rare, chronic condition is truly exciting news for our community and at the core of the mission of the Scleroderma Research Foundation to improve the lives of patients."

Ofev patient support
To support people who are prescribed Ofev, Boehringer Ingelheim has developed OPEN DOORS^® ? a comprehensive patient support program that provides a broad range of nursing, social resources, and financial support services. Accessible through www.ofev.com and at 1-866-673-6366, OPEN DOORS services and resources include:

• Access to nurse support 24 hours a day, 7 days a week
• Social resource services to identify local resources, such as support groups and transporation to doctor appointments
• Assistance in finding financial resources to support access to Ofev
• Access to educational information about IPF and SSc-ILD

What is OFEV?

• OFEV is a prescription medicine used:
• to treat people with a lung disease called idiopathic pulmonary fibrosis (IPF).

or

• 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 (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 highly effective birth control during 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. Women using hormonal birth control should add a barrier method of birth control (such as male condoms or spermicide). 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-100024  09.06.19

About Boehringer Ingelheim Pharmaceuticals, Inc.

Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, Conn., 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 our goal is to improve the lives of humans and animals through its three business areas: human pharmaceuticals, animal health and biopharmaceutical contract manufacturing.

Boehringer Ingelheim concentrates on developing innovative therapies that can improve patients' lives. As a research-driven pharmaceutical company, it plans in generations for long-term success. Its research efforts are focused on diseases with high, unmet medical need. In animal health, the company stands for advanced prevention.

In 2018, Boehringer Ingelheim achieved net sales of around $20.7 billion (17.5 billion euros). R&D expenditure of almost $3.7 billion (3.2 billion euros) corresponded to 18.1 per cent of net sales.

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Contact:
Boehringer Ingelheim Pharmaceuticals, Inc.
Name: Paul Wynn
Public Relations
Phone: 203-482-4512
Email: [email protected]

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