New data showed OFEV® (nintedanib) slows decline of lung function in broad range of chronic fibrosing interstitial lung diseases with a progressive phenotype(1)

Wednesday, October 9, 2019 General News
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BURLINGTON, ON, Oct. 9, 2019 /CNW/ - Boehringer Ingelheim announced today that in the Phase III INBUILD® trial nintedanib slowed lung function decline by 57% across the overall study population, as assessed by the annual rate of decline in forced vital capacity (FVC)i over 52 weeks in patients with chronic fibrosing interstitial lung disease (ILDs)

with signs of progression.1 Just published in the New England Journal of Medicine and to be presented at the ERS Congress in Madrid, Spain, the study has met its primary endpoint and demonstrated the efficacy and safety of nintedanib in patients with a broad range of progressive fibrosing interstitial lung diseases other than idiopathic pulmonary fibrosis (IPF).1

"Patients suffering from different ILDs have variable, often irreversible damage to their lungs with a poor prognosis. Unfortunately, to date there are no medications approved for the treatment of progressive fibrosing ILDs, except for IPF," explained Dr. Martin Kolb, Director, Division of Respirology, Department of Medicine, McMaster University. "The recent results of the INBUILD trial identified conclusively that OFEV slowed the decline of pulmonary function in patients who suffer from progressive pulmonary fibrosis, across the ILD spectrum."

Chronic hypersensitivity pneumonitis, autoimmune ILDs such as rheumatoid arthritis-associated ILD, systemic sclerosis-associated ILD (SSc-ILD), mixed connective tissue disease-associated ILD, sarcoidosis and idiopathic forms of interstitial pneumonias, i.e. non-specific interstitial pneumonia, and unclassified idiopathic interstitial pneumonia, are among these diseases. Nintedanib was shown to slow the rate of ILD progression independent of the fibrotic pattern seen on chest imaging.1 The side effect profile was consistent with previous studies of nintedanib in ILDs, with diarrhea being the most common adverse event.1

"We are very proud to be presenting the results of this first ever clinical trial studying patients with different forms of progressive fibrosing ILDs, which are the basis of the regulatory applications that were recently submitted with the FDA and EMA," commented Dr. Mehdi Shahidi, M.D., Chief Medical Officer, Boehringer Ingelheim. "We are absolutely committed to improving the lives of people living with pulmonary fibrosis, in particular those affected by rare diseases with a high level of unmet need."

About the INBUILD® TrialINBUILD® is the first clinical trial in the field of ILDs to group patients based on the clinical behaviour of their disease, rather than the primary clinical diagnosis.1 ILDs encompass a large group of more than 200 disorders that may involve the threat of pulmonary fibrosis – an irreversible scarring of lung tissue that negatively impacts lung function.2 Patients with ILD can develop a progressive phenotype that causes pulmonary fibrosis, leading to lung function decline, deterioration in quality of life and early mortality similar to IPF, the most frequent form of idiopathic interstitial pneumonias.3 The course of the disease and the symptoms are similar in progressive fibrosis ILDs regardless of the underlying disease.4

In the INBUILD® trial, nintedanib slowed lung function decline by 57% across the overall study population, with an adjusted annual rate of decline over 52 weeks in FVC of -80.8 mL/year compared to -187.8 mL/year for placebo (difference, 107.0 mL/year [95% CI, 65.4 to 148.5]; p<0.001).1 OFEV ­­­­­demonstrated a consistent effect on lung function decline in patients with a usual interstitial pneumonia (UIP) like fibrotic pattern and those with other fibrotic patterns on HRCT.1 The most common adverse event was diarrhea, reported in 66.9% and 23.9% of patients treated with nintedanib and placebo, respectively.1 The safety profile observed in INBUILD® was consistent to what has been seen in IPF and SSc-ILD patients treated with nintedanib previously.1

-----------------------[i] FVC is Forced Vital Capacity, an established measure of lung function

About NintedanibNintedanib 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. Over 70,000 people with IPF have been treated with nintedanib.Progressive Fibrosing Interstitial Lung DiseaseThe course of the disease and the symptoms are similar in progressive fibrosing interstitial lung diseases regardless of the underlying condition.4 There is an accelerated loss of lung function, a deterioration in quality of life and the disease is associated with a poor prognosis.3

The progressive fibrosis of the lung leads to an irreversible loss of lung function and is associated with high morbidity and mortality. On average, 18-32% of patients with ILD might develop a progressive pulmonary fibrosis.5 Progressive fibrosing interstitial lung diseases encompass a range of clinical diagnoses, including: hypersensitivity pneumonitis, sarcoidosis, autoimmune ILDs such as rheumatoid arthritis-associated ILD, systemic sclerosis-associated ILD, mixed connective tissues disease-associated ILD, idiopathic non-specific interstitial pneumonia, and unclassified idiopathic interstitial pneumonia amongst others.3

Patients with progressive fibrosing interstitial lung diseases are a neglected patient population for whom no approved treatment options exist that effectively influence the course of their disease. Therapy of progressive fibrosing interstitial lung diseases is therefore a challenge that requires interdisciplinary care, especially by pulmonologists and rheumatologists.3

Boehringer Ingelheim (Canada) Ltd. Improving the health of humans and animals is the goal of Boehringer Ingelheim, a research-driven pharmaceutical company. In doing so, the focus 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 top 20 companies in the pharmaceutical industry. Some 50,000 employees create value through innovation daily for the three business areas of human pharmaceuticals, animal health and biopharmaceuticals. In 2018, Boehringer Ingelheim achieved net sales of around 17.5 billion euros. R&D expenditure of almost 3.2 billion euros, corresponded to 18.1 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.

The Canadian headquarters of Boehringer Ingelheim was established in 1972 in Montreal, Quebec and is now located in Burlington, Ontario. Boehringer Ingelheim employs approximately 600 people across Canada.

More information about Boehringer Ingelheim can be found at www.boehringer-ingelheim.ca or in our annual report: http://annualreport.boehringer-ingelheim.com/.

For more information, please contact:

Sara McClelland Boehringer Ingelheim (Canada) Ltd. sara.mcclelland@boehringer-ingelheim.com 905-631-4713

Robbyn Walsh Proof Inc. rwalsh@getproof.com 416-969-2759

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1 Flaherty K, et al. Nintedanib in Progressive Fibrosing Interstitial Lung Diseases N Eng J Med. Published 29 September, 2019. NEJM.org. DOI: 10.1056/NEJMoa19086812 British Lung Foundation. What is pulmonary fibrosis? Available at: https://www.blf.org.uk/support-for-you/pulmonary-fibrosis/what-is-pulmonary-fibrosis [Accessed September 2019].3 Cottin V, Hirani NA, Hotchkin DL, et al. Presentation, diagnosis and clinical course of the spectrum of progressive-fibrosing interstitial lung diseases. Eur Respir Rev 2018;27(150):pii:180076.4 Kolb M, Vašáková M. The natural history of progressive fibrosing interstitial lung diseases. Respiratory Research 2019:20:57.5 Wijsenbeek M, Kreuter M, Fischer A, et al. Non-IPF progressive fibrosing interstitial lung disease (PF-ILD): the patient journey. Am J Respir Crit Care Med 2018;197:A1678.

SOURCE Boehringer Ingelheim (Canada) Ltd.



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