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Boehringer Ingelheim Announces FDA and EMA Regulatory Submission for Nintedanib in Systemic Sclerosis Associated ILD

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Tuesday, March 19, 2019

Ridgefield, Conn., – 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
It is estimated that up to 2.5 million people worldwide have scleroderma, including approximately 100,000 people in the United States. Because scleroderma affects the connective tissue, symptoms can occur in any area of the body including the skin, muscles, blood vessels, lungs and other internal organs, making it difficult to diagnose. The disease impacts four times as many women as men, and the onset of the disease typically occurs at a young age – between 25 and 55 years.

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.

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 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.

Source: boehringer
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