Boehringer Ingelheim announces FDA and EMA regulatory submission for nintedanib in systemic sclerosis associated ILD

Boehringer IngelheimBoehringer 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 as an anti-fibrotic medicine is already approved in more than 70 countries for the treatment of patients living with idiopathic pulmonary fibrosis (IPF).

Systemic sclerosis, also known as scleroderma, is a rare disease characterised by thickening and scarring of connective tissue throughout the body.(1,2) The disease can cause scarring of the skin, lungs (interstitial lung disease), heart and kidneys which can be debilitating and may become life-threatening.(1,2) Approximately 25% of patients develop significant pulmonary involvement within three years of diagnosis.(3) Lung involvement is the leading cause of death among people with systemic sclerosis.(1)

Dr. Susanne Stowasser, 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."

The regulatory submissions are part of Boehringer Ingelheim’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 (17-22 May).

About nintedanib

Nintedanib is already approved in more than 70 countries for the treatment of patients living with idiopathic pulmonary fibrosis (IPF) - a chronic and ultimately fatal disease characterised by a decline in lung function.

Further background on systemic sclerosis

It is estimated that up to 2.5 million people worldwide have scleroderma(4). Because scleroderma affects the connective tissue, symptoms can occur in any area of the body including the skin, muscles, blood vessels and internal organs, making it difficult to diagnose.(5) 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.(5)

About Boehringer Ingelheim

Improving the health and quality of life of patients is the goal of the research-driven pharmaceutical company Boehringer Ingelheim. The focus in doing so is on diseases for which no satisfactory treatment option exists to date. The company therefore concentrates on developing innovative therapies that can extend patients' lives. In animal health, Boehringer Ingelheim stands for advanced prevention.

Family-owned since it was established in 1885, Boehringer Ingelheim is one of the pharmaceutical industry's top 20 companies. Some 50,000 employees create value through innovation daily for the three business areas human pharmaceuticals, animal health and biopharmaceuticals. In 2017, Boehringer Ingelheim achieved net sales of nearly 18.1 billion euros. R&D expenditure, exceeding three billion euros, corresponded to 17.0 per cent of net sales.

As a family-owned company, Boehringer Ingelheim plans in generations and focuses on long-term success. The company therefore aims at organic growth from its own resources with simultaneous openness to partnerships and strategic alliances in research. In everything it does, Boehringer Ingelheim naturally adopts responsibility towards mankind and the environment.

1. Solomon JJ, Olson A L, Fischer A, et al. European Respiratory Update: Scleroderma lung disease. Eur.Respir. Rev. 2013; 22: 127, 6-19.
2. Denton CP, Khanna D. Systemic sclerosis. www.thelancet.com (link is external) Published online April 13, 2017 http://dx.doi.org/10.1016/S0140-6736(17)30933-9 (link is external). Last accessed March 2019.
3. McNearney TA, Reveille JD, Fischbach M, et al. Pulmonary involvement in systemic sclerosis: associations with genetic, serologic, sociodemographic, and behavioral factors. Arthritis Rheum. 2007;57(2):318-326.
4. Scleroderma & Raynauds UK (SRUK) https://www.sruk.co.uk/scleroderma/what-scleroderma/ (link is external) Last accessed March 2019.
5. Scleroderma Foundation. What is scleroderma? Available at: http://www.scleroderma.org/site/PageNavigator/patients_whatis.html#.V%20hgSaPlViko (link is external). Last accessed March 2019.

Most Popular Now

Bayer, Bristol-Myers Squibb and Ono Pharmaceutical…

Bayer, Bristol-Myers Squibb Company (NYSE: BMY) and Ono Pharmaceutical Co., Ltd. ("Ono") announced today the three companies have entered into a clinical collaboration ag...

Amgen and Allergan's MVASI™ (bevacizumab-awwb) and…

Amgen (NASDAQ:AMGN) and Allergan plc (NYSE:AGN) announced that MVASI™ (bevacizumab-awwb), a biosimilar to Avastin® (bevacizumab), and KANJINTITM (trastuzumab-anns), a bio...

Compound found in red wine opens door for new trea…

Like to unwind with a glass of red wine after a stressful day? Don't give alcohol all the credit. New research has revealed that the plant compound resveratrol, which is ...

HIV vaccine nears clinical trial following new fin…

A promising vaccine that clears an HIV-like virus from monkeys is closer to human testing after a new, weakened version of the vaccine has been shown to provide similar p...

Mylan and Upjohn, a division of Pfizer, to combine…

HERTFORDSHIRE, England & PITTSBURGH & Mylan N.V. (Nasdaq: MYL) and Pfizer Inc. (NYSE: PFE) today announced a definitive agreement to combine Mylan with Upjohn, Pfizer's o...

Leading oncologists and nutritionists pinpoint are…

An international collaborative led by Ludwig Cancer Research and Cancer Research UK has identified key areas that are central to uncovering the complex relationship betwe...

Closing the door: breaking new ground related to a…

In order to sustain fast growth, cancer cells need to take up nutrients at a faster rate than healthy cells. The human glutamine transporter ASCT2 allows the amino acid g...

FDA approves first generics of Lyrica

On July 19, the U.S. Food and Drug Administration approved multiple applications for first generics of Lyrica (pregabalin) for the management of neuropathic pain associat...

Roche and Spark Therapeutics, Inc. announce extens…

Roche (SIX: RO, ROG; OTCQX: RHHBY) and Spark Therapeutics, Inc. (NASDAQ: ONCE) ("Spark") announced that Roche has extended the offering period of its previously announced...

FDA approves first treatment for severe hypoglycem…

The U.S. Food and Drug Administration today approved Baqsimi nasal powder, the first glucagon therapy approved for the emergency treatment of severe hypoglycemia that c...

Rye is healthy, thanks to an interplay of microbes

Eating rye comes with a variety of health benefits. A new study from the University of Eastern Finland now shows that both lactic acid bacteria and gut bacteria contribut...

GSK completes transaction with Pfizer to form new …

The Joint Venture brings together two highly complementary portfolios of trusted consumer health brands, including GSK's Sensodyne, Voltaren and Panadol and Pfizer's Advi...