FDA approves Ofev® as first treatment for chronic fibrosing ILDs with a progressive phenotype

RIDGEFIELD, Conn., March 9, 2020 /PRNewswire/ -- Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) approved Ofev® (nintedanib) as the first treatment for people with chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype. Unclassifiable ILDs, autoimmune ILDs, chronic hypersensitivity pneumonitis, sarcoidosis, myositis, sjogren's syndrome, coal workers pneumoconiosis and idiopathic forms of interstitial pneumonias such as idiopathic non-specific interstitial pneumonia are among the diseases that may develop a progressive form of chronic fibrosing ILD.

Ofev, a multi-targeted tyrosine kinase inhibitor that inhibits key pathways involved in lung fibrosis in ILDs, is currently approved for idiopathic pulmonary fibrosis (IPF) and to slow the rate of decline in pulmonary function in patients with systemic sclerosis-associated ILD (SSc-ILD), two types of ILDs. Ofev received Breakthrough Therapy Designation from the U.S. FDA for chronic fibrosing ILDs with a progressive phenotype in October 2019. This new approval now makes Ofev available for patients with chronic fibrosing ILDs in which lung fibrosis continues to worsen.

The FDA approval is based on the INBUILD® trial, the first Phase III clinical trial in the field of ILDs to group patients based on the clinical behavior of their disease rather than the primary clinical diagnosis. In this trial, the safety and tolerability profile of Ofev was consistent with what was previously seen in IPF studies. The most common adverse reactions reported in greater than or equal to five percent in Ofev-treated patients compared to placebo were diarrhea, nausea, abdominal pain, vomiting, liver enzyme elevation, decreased appetite, weight decreased, headache, hypertension, nasopharygitis, upper respiratory tract infection, urinary tract infections, fatigue and back pain. Please see additional Important Safety Information included below.

"Chronic fibrosing ILDs with a progressive phenotype lead to respiratory symptoms and worsening lung function," said Kevin Flaherty, M.D., professor of medicine, Division of Pulmonary and Critical Care Medicine, University of Michigan in Ann Arbor, Michigan, and lead investigator of the INBUILD trial. "This approval provides a therapeutic option for many patients who did not have an approved treatment until today."

Interstitial lung diseases encompass more than 200 disorders, which are classified as rare diseases, that can lead to pulmonary fibrosis ? an irreversible scarring of lung tissue that negatively impacts lung function. Chronic fibrosing ILDs in which lung fibrosis continues to worsen are estimated to occur in 18 to 32 percent of patients with ILDs. 

"As a leader in the field of ILD research, we are fully committed to better understanding how to treat these devastating diseases," said Thomas Seck, M.D., senior vice president, Medicine & Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "Today's approval marks a major advancement in ILD research and is an important milestone just six months after the approval of Ofev to slow the rate of decline in pulmonary function in patients with SSc-ILD."

"Patients with a progressive form of chronic fibrosing ILDs may have symptoms that are similar to other respiratory illnesses and that may delay getting an accurate diagnosis for patients," said Greg Cosgrove, M.D., chief medical officer, Pulmonary Fibrosis Foundation. "The new indication for nintedanib provides a therapeutic option for physicians and their patients as there is now a treatment option that can help slow the decline in lung function."

About the Phase III INBUILD trial
The INBUILD trial, which was published in the New England Journal of Medicine, was a randomized, double-blind, placebo-controlled, parallel group trial conducted at 153 sites in 15 countries that evaluated the efficacy and safety of Ofev (150 mg, twice-daily) over 52 weeks in patients with chronic fibrosing ILDs with a progressive phenotype. A total of 663 patients were evaluated, of whom 412 (62.1 percent) had a usual interstitial pneumonia (UIP)-like pattern on high-resolution CT (HRCT). Randomization of patients was based on the fibrotic patterns as detected through HRCT. Lung function was assessed by the annual rate of decline in forced vital capacity (FVC), which is an established measurement of lung function.

Results showed that Ofev slowed the loss of pulmonary function by 57 percent (107 mL/year) across a range of patients relative to placebo. In patients with UIP-like fibrotic pattern on HRCT, results showed that treatment with Ofev-versus placebo slowed the loss of pulmonary function by 61 percent (128.2mL/year).

In this trial, the safety and tolerability profile of Ofev was consistent with what was previously seen in IPF studies, with the most common adverse reaction being diarrhea.

About Ofev
Ofev is already approved in the U.S. and more than 75 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.

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 transportation to doctor appointments
• Assistance in finding financial resources to support access to Ofev
• Access to educational information on IPF, SSc-ILD and 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).
  or
• to treat people with a chronic (long lasting) interstitial lung disease in which lung fibrosis continues to worsen (progress).
  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 also use 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 http://www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see full Prescribing Information, including Patient Information.

CL-OF-100032 03.2020

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

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

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