OFEV® (nintedanib) receives positive recommendation from CADTH and INESSS for the treatment of progressive fibrosing interstitial lung diseases (PF-ILD)

• OFEV^® is the first treatment available in Canada for chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype (also known as PF-ILD), which affects patients across more than 200 rare lung disorders^1,2
• OFEV^® slowed lung function decline in PF-ILD patients by 57 per cent compared to placebo in the INBUILD^® clinical trial³

Burlington, ON, March 4, 2021 /CNW/ - Boehringer Ingelheim (Canada) Ltd. is pleased to announce positive recommendations from the Canadian Agency for Drugs and Technologies in Health (CADTH) and the Institut national d'excellence en santé et services sociaux (INESSS) for OFEV^® (nintedanib) for the treatment of chronic fibrosing interstitial lung diseases with a progressive phenotype (also known as PF-ILD) when certain conditions are met.^4,5

Full details on the recommendations, including recommended criteria for reimbursement, are available on the CADTH and INESSS websites, respectively.

 "As the first treatment available to manage PF-ILD, OFEV^®, has the potential to fundamentally change the future outlook for patients who would otherwise expect their breathing to become progressively more difficult," says Dr. Shane Shapera, M.D., Director of the Interstitial Lung Disease Program at the Toronto General Hospital Division of the University Health Network. "With this recommendation from CADTH and INESSS, patients are one step closer to receiving this much needed treatment sooner, to help slow the decline in lung function, giving them the opportunity to continue to do the things that matter most to them."  

Interstitial lung diseases (ILDs) encompass more than 200 disorders, which are classified as rare diseases, that can lead to pulmonary fibrosis – an irreversible scarring of lung tissue that negatively impacts lung function.^6,7 Chronic fibrosing ILDs in which lung fibrosis continues to worsen are estimated to occur in 18 to 32 percent of patients with ILDs.⁸

The recommendations for reimbursement are supported by the results of the INBUILD^® clinical trial, which showed that OFEV^® slowed the rate of lung function decline by 57 per cent across the overall study population versus placebo.⁹

About OFEV^®

OFEV^® recently received authorization for sale for patients with PF-ILD by Health Canada, the FDA and the European Commission. OFEV^®, a multi-targeted tyrosine kinase inhibitor that inhibits key pathways involved in lung fibrosis in ILDs,¹⁰ 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.¹¹

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 disease course.¹² 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).¹³ 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.¹⁴

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).¹⁵

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.¹⁶

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.

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¹ Ofev® Product Monograph. Boehringer Ingelheim (Canada) Ltd. May 19, 2020.

² British Lung Foundation. What is pulmonary fibrosis? Available at: https://www.blf.org.uk/support-for-you/pulmonary-fibrosis/what-is-pulmonary-fibrosis

³ Ofev® Product Monograph. Boehringer Ingelheim (Canada) Ltd. May 19, 2020.

⁴ CADTH (2021). Available at: https://cadth.ca/sites/default/files/cdr/complete/SR0654%20Ofev%20-%20Final%20CDEC%20Recommendation%20February%2026%2C%202021_For%20Posting.pdf. Accessed February 26, 2021.

⁵ INESSS (2021). Available at: https://www.inesss.qc.ca/fileadmin/doc/INESSS/Inscription_medicaments/Avis_au_ministre/Mars_2021/Ofev_2021_02.pdf. Accessed March 3, 2021. 

⁶ British Lung Foundation. Pulmonary Fibrosis.https://www.blf.org.uk/support-for-you/pulmonary-fibrosis/what-is-pulmonary-fibrosis

⁷ 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.

⁸ Wijsenbeek M, et al. Non-IPF progressive fibrosing interstitial lung diseases: the patient journey. Poster presented at the American Thoracic Society International Conference, San Diego, CA, USA, 18–23.

⁹ Ofev® Product Monograph. Boehringer Ingelheim (Canada) Ltd. May 19, 2020.

¹⁰ Ofev® Product Monograph. Boehringer Ingelheim (Canada) Ltd. May 19, 2020.

¹¹ Ofev® Product Monograph. Boehringer Ingelheim (Canada) Ltd. May 19, 2020.

¹² Flaherty KR, Wells AU, Cottin V, et al. Nintedanib in Progressive Fibrosing Interstitial Lung Diseases. N Engl J Med. 2019;381(18):1718-1727.

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.

SOURCE Boehringer Ingelheim (Canada) Ltd.

Anne Coffey, Boehringer Ingelheim (Canada) Ltd., [email protected], [phone]