GSK’s Nucala (mepolizumab) accepted for review by Health Canada for the treatment of COPD

  •  Submission supported by MATINEE data showing significant and clinically meaningful reduction in annualized rate of moderate/severe exacerbations compared with placebo

MISSISSAUGA, ON - GSK has submitted a Supplementary New Drug Submission (SNDS) to Health Canada to expand the use of Nucala (mepolizumab) to include add-on maintenance treatment for adult patients with chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype. If approved, Nucala could be the first biologic with monthly dosing available in Canada for patients with COPD.

The SNDS is based on data from the MATINEE study, which evaluated the efficacy and safety of mepolizumab in 804 patients with COPD who have evidence of type 2 inflammation characterized by blood eosinophil count.1 The trial recruited COPD patients with broad clinical presentations including hard to treat patients with emphysema-only, chronic bronchitis only, or a mix of both. Currently these patients have limited treatment options and are at risk of poor outcomes.

Nucala, an anti-interleukin-5 (IL-5) monoclonal antibody, is currently approved in Canada for the treatment of severe eosinophilic asthma, chronic rhinosinusitis with nasal polyps, eosinophilic granulomatosis with polyangiitis (EGPA), and hypereosinophilic syndrome (HES). If approved for COPD, Nucala would offer a new therapeutic option for those COPD patients with eosinophilic inflammation who continue to experience exacerbations despite standard treatments.

“This marks a significant step forward in our commitment to providing innovative treatment options for patients suffering from respiratory diseases. We remain dedicated to advancing respiratory care and we look forward to working closely with the regulatory authorities during the review process,” said Michelle Horn, Country Medical Director, GSK Canada

COPD is a progressive and life-threatening lung disease that affects around 2 million Canadians.2 The Nucala submission for the treatment of COPD underscores GSK’s dedication to developing targeted therapies that address the underlying mechanisms of respiratory diseases. The safety and effectiveness of Nucala for adult patients with COPD with an eosinophilic phenotype are still under investigation and authorization has not yet been granted.

About chronic obstructive pulmonary disease

COPD is a progressive and heterogenous inflammatory lung disease that includes chronic bronchitis and emphysema, and is the third leading cause of death resulting in more than 3 million deaths annually worldwide.3,4 Patients with COPD experience persistent respiratory symptoms such as breathlessness, cough, and sputum along with progressive airflow obstruction due to the chronic inflammation that impact daily life.3 Exacerbations are acute episodes of worsening COPD symptoms and can result in hospitalization and irreversible lung damage that leads to progressive lung function decline. Exacerbations can result in a cycle of deterioration in overall physical health and increased mortality.3,5 Many patients experience persistent symptoms and exacerbations meaning there is a need for targeted therapies to address the underlying pathophysiology linked to disease progression.3,6-8

About Nucala

First approved in 2015 for severe eosinophilic asthma in Canada, mepolizumab is a monoclonal antibody that targets and binds to interleukin-5 (IL-5), a key messenger protein (cytokine) in type 2 Inflammation.
Nucala is currently indicated in Canada:

  • as add-on maintenance treatment for adults, adolescents, and children (aged 6 years and older) with severe eosinophilic asthma who:
    • are inadequately controlled with high-dose inhaled corticosteroids (patients ≥ 18 years of age) or medium-to-high-dose inhaled corticosteroids (patients 6-17 years of age) and an additional asthma controller(s) (e.g., LABA); and
    • have a blood eosinophil count of ≥ 150 cells/μL (0.15 GI/L) at initiation of treatment with Nucala OR ≥ 300 cells/μL (0.3 GI/L) in the past 12 months.
  • as add-on maintenance treatment with intranasal corticosteroids in adult patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP) inadequately controlled by intranasal corticosteroids alone.
  • as an add-on to corticosteroids for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA).
  • as an add-on to standard therapy for the treatment of adult patients with hypereosinophilic syndrome (HES) for ≥6 months without an identifiable non-hematologic secondary cause.

About GSK in respiratory

GSK continues to build on decades of pioneering work to deliver more ambitious treatment goals, develop the next generation standard of care, and redefine the future of respiratory medicine for hundreds of millions of people with respiratory diseases. With an industry-leading respiratory portfolio and pipeline of vaccines, targeted biologics and inhaled medicines, we are focused on improving outcomes and the lives of people living with all types of asthma and COPD along with less understood refractory chronic cough or rarer conditions like systemic sclerosis with interstitial lung disease. GSK is harnessing the latest science and technology with the aim to modify underlying disease dysfunction and prevent disease progression.

About GSK

GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.ca.

References

1 gov. Mepolizumab as Add-on Treatment IN Participants With COPD Characterized by Frequent Exacerbations and Eosinophil Level (MATINEE) Available at: https://clinicaltrials.gov/study/NCT04133909.

2 Canadian Lung Association: “What is COPD?” https://www.lung.ca/lung-health/lung-diseases/chronic-obstructive-pulmonary-disease-copd/what-copd.

3 GOLD Science Committee Members (2023-2024). The Global Strategy for Diagnosis, Management and Prevention of CO 2024. Available at: goldcopd.org

4 Boers E, et al. Global Burden of Chronic Obstructive Pulmonary Disease Through 2050. JAMA Netw Open. 2023;6(12).

5 S. Food and Drug Administration. Nucala Full Prescribing Information. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761122s000lbl.pdf.

6 Hurst J R, et al. Susceptibility to Exacerbation in Chronic Obstructive Pulmonary Disease. N Engl J Med. 2010;363:1128-38.

8 Whittaker H, et al. Frequency and Severity of Exacerbations of COPD Associated with Future Risk of Exacerbations and Mortality: A UK Routine Health Care Data Study. Int J Chron Obstruct Pulmon Dis. 2022;17:427-437.Rabe KF, et al. Targeting Type 2 Inflammation and Epithelial Alarmins in Chronic Obstructive Pulmonary Disease: A Biologics Outlook. Am J Respir Crit Care Med. 2023;208(4):395-405.