Boehringer Ingelheim announces FDA and EMA regulatory submission for nintedanib in systemic sclerosis associated ILD
RIDGEFIELD, Conn., March 18, 2019 /PRNewswire/ -- Boehringer Ingelheim has filed for regulatory approval of nintedanib in patients with systemic sclerosis associated interstitial lung disease (SSc-ILD) with the FDA and EMA. Nintedanib, which is marketed as Ofev®, is 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 disease progression as measured by reducing the annual rate of decline in lung function.
Systemic sclerosis, also known as scleroderma, is a rare disease characterized by thickening and scarring of connective tissue throughout the body. The disease can cause scarring of the skin, lungs (interstitial lung disease), heart and kidneys which can be debilitating and may become life-threatening. Approximately 25 percent of patients develop significant pulmonary involvement within three years of diagnosis. Lung involvement is the leading cause of death among people with systemic sclerosis.
Susanne Stowasser, M.D., Associate Head of Respiratory Medicine at Boehringer Ingelheim, said: "Systemic sclerosis associated interstitial lung disease has a devastating impact on those it affects – often women in the prime of their lives. Pulmonary fibrosis is a key driver of mortality in systemic sclerosis, and currently there are no approved treatments for SSc-ILD. Boehringer Ingelheim is pleased that we are able to take a step closer to potentially bringing an approved treatment for addressing the decline in lung function to patients with this rare condition."
Because SSc-ILD and IPF share similarities in how the underlying lung scarring, or fibrosis, forms in people with the disease, Boehringer Ingelheim evaluated the impact of nintedanib in patients with SSc-ILD. The regulatory submissions are part of the company's ongoing commitment to improving the lives of people living with pulmonary fibrosis, in particular those affected by rare diseases with a high level of unmet need.
Clinical research results relating to nintedanib in SSc-ILD will be shared with the scientific community during the American Thoracic Society Congress (May 17-22).
About systemic sclerosis
What is Ofev?
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:
Tell your doctor if you:
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:
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/safety/medwatch or call 1-800-FDA-1088.
About Boehringer Ingelheim Pharmaceuticals, Inc.
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 www.boehringer-ingelheim.us/csr to learn more about how we make more health through our Corporate Social Responsibility initiatives.
In 2017, Boehringer Ingelheim achieved net sales of about $20.4 billion (18.1 billion euros). R&D expenditure corresponds to approximately $3.4 billion (three billion euros), or 17.0 percent of its net sales.
For more information please visit www.boehringer-ingelheim.us, or follow us on Twitter @BoehringerUS.
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SOURCE Boehringer Ingelheim Pharmaceuticals