May 26th, 2020

// OFEV® (nintedanib) now available in Canada for adults living with progressive fibrosing interstitial lung diseases (PF-ILD)(1)

OFEV® (nintedanib) now available in Canada for adults living with progressive fibrosing interstitial lung diseases (PF-ILD)(1)

  • OFEV® is the first treatment available in Canada for progressive fibrosing interstitial lung diseases (PF-ILD), which affects patients across a wide variety of interstitial lung diseases (ILDs)2
  • It is estimated that 18 to 32% of patients diagnosed with chronic ILDs develop a progressive fibrosing phenotype3
  • OFEV® slowed lung function decline in PF-ILD patients by 57% compared to placebo4

BURLINGTON, ON, May 25, 2020 /CNW/ - Boehringer Ingelheim (Canada) Ltd. announced today that OFEV® (nintedanib) is authorized for sale by Health Canada for the treatment of other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype (also known as progressive fibrosing ILD).5 Interstitial lung diseases (ILDs) encompass more than 200 disorders that can lead to irreversible scarring of lung tissue, negatively impacting lung function.6 An estimated 18 to 32 per cent of patients with ILDs will develop a progressive fibrosing course of the disease.7 This new indication now makes OFEV® available for patients with progressive fibrosing ILDs in which lung fibrosis continues to worsen.8

"Progressive fibrosing ILDs have a significant impact on patients, including worsening lung function and lessening quality of life," says Dr. Martin Kolb, a respirologist at St. Joseph's Healthcare Hamilton, Director, Division of Respirology at McMaster University, and clinical investigator in the INBUILD® trial. "With this new indication, we now have a therapeutic option to help improve outcomes in ILD patients across the spectrum."

The new indication is based on the INBUILD® trial, the first Phase III trial in the field of ILDs to group patients based on the clinical behavior of their disease rather than the primary clinical diagnosis.9 Results showed that OFEV® slowed the rate of lung function decline by 57 per cent across the overall study population.10

"As a leader in the field of ILD research, Boehringer Ingelheim is committed to developing innovative treatments to make a significant difference to patients' lives," says Dr. Uli Brödl, Vice President, Medical and Regulatory Affairs, Boehringer Ingelheim (Canada) Ltd. "Until today, there was no available treatment for PF-ILD; OFEV® offers new hope for patients suffering from these devastating diseases."

OFEV®, a multi-targeted tyrosine kinase inhibitor that inhibits key pathways involved in lung fibrosis in ILDs,11 is also indicated for the treatment of 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.12

"Canadian Pulmonary Fibrosis Foundation (CPFF) is pleased to see a treatment for patients with progressive fibrosing ILD (PF-ILD), which often leads to irreversible damage to their lungs and makes it difficult to breathe and do everyday tasks," says Sharon Lee, Executive Director, CPFF. "Canadian patients with progressive ILDs now have access to a therapeutic option and the hope it brings to focus on life beyond their diagnosis." 

About the 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.13 A total of 663 patients were evaluated, of whom 412 (62.1 per cent) had a usual interstitial pneumonia (UIP)-like pattern on high-resolution CT (HRCT).14 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.15

Results showed that OFEV® slowed the loss of pulmonary function by 57 per cent (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 per cent (128.2mL/year).16 

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.17

Both the FDA and Health Canada have authorized the use of OFEV® in PF-ILD. This new indication is a part of the company's ongoing commitment to improving the lives of people living with ILDs.

Boehringer Ingelheim (Canada) Ltd. 
Making new and better medicines for humans and animals is at the heart of what we do. Our mission is to create breakthrough therapies that change lives. Since its founding in 1885, Boehringer Ingelheim is independent and family-owned. We have the freedom to pursue our long-term vision, looking ahead to identify the health challenges of the future and targeting those areas of need where we can do the most good.

As a world-leading, research-driven pharmaceutical company, more than 51,000 employees create value through innovation daily for our three business areas: Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing. In 2019, Boehringer Ingelheim achieved net sales of 19 billion euros. Our significant investment of almost 3.5 billion euros in R&D drives innovation, enabling the next generation of medicines that save lives and improve quality of life.

We realize more scientific opportunities by embracing the power of partnership and diversity of experts across the life-science community. By working together, we accelerate the delivery of the next medical breakthrough that will transform the lives of patients now, and in generations to come.

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.          

References 
________________________
1 Ofev® Product Monograph. Boehringer Ingelheim (Canada) Ltd. May 19, 2020. 
2 Ofev® Product Monograph. Boehringer Ingelheim (Canada) Ltd. May 19, 2020. 
3 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.
4 Ofev® Product Monograph. Boehringer Ingelheim (Canada) Ltd. May 19, 2020.
5 Ofev® Product Monograph. Boehringer Ingelheim (Canada) Ltd. May 19, 2020. 
6 British Lung Foundation. What is pulmonary fibrosis? Available at: https://www.blf.org.uk/support-for-you/pulmonary-fibrosis/what-is-pulmonary-fibrosis [Accessed May 2020].
7 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.
8 Cottin V, Wollin L, Fischer A, Quaresma M, Stowasser S, Harari S. Fibrosing interstitial lung diseases: knowns and unknowns. Eur Respir Rev. 2019;28(151)
9 Flaherty KR, Wells AU, Cottin V, et al. Nintedanib in Progressive Fibrosing Interstitial Lung Diseases. N Engl J Med. 2019;381(18):1718-1727.
10 Ofev® Product Monograph. Boehringer Ingelheim (Canada) Ltd. May 19, 2020.
11 Ofev® Product Monograph. Boehringer Ingelheim (Canada) Ltd. May 19, 2020.
12 Ofev® Product Monograph. Boehringer Ingelheim (Canada) Ltd. May 19, 2020.
13 Flaherty KR, Wells AU, Cottin V, et al. Nintedanib in Progressive Fibrosing Interstitial Lung Diseases. N Engl J Med. 2019;381(18):1718-1727.
14 Flaherty KR, Wells AU, Cottin V, et al. Nintedanib in Progressive Fibrosing Interstitial Lung Diseases. N Engl J Med. 2019;381(18):1718-1727.
15 Flaherty KR, Wells AU, Cottin V, et al. Nintedanib in Progressive Fibrosing Interstitial Lung Diseases. N Engl J Med. 2019;381(18):1718-1727.
16 Flaherty KR, Wells AU, Cottin V, et al. Nintedanib in Progressive Fibrosing Interstitial Lung Diseases. N Engl J Med. 2019;381(18):1718-1727.
17 Flaherty KR, Wells AU, Cottin V, et al. Nintedanib in Progressive Fibrosing Interstitial Lung Diseases. N Engl J Med. 2019;381(18):1718-1727.

SOURCE Boehringer Ingelheim (Canada) Ltd.

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