Exdensur (depemokimab injection) approved in Canada for the treatment of severe asthma and chronic rhinosinusitis with nasal polyps
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- Exdensur is the first and only long-acting biologic with twice-yearly dosing approved in Canada for severe asthma characterized by an eosinophilic phenotype and chronic rhinosinusitis with nasal polyps (CRSwNP).
- In Canada, approximately half of people living with asthma remain uncontrolled, with asthma attacks leading to more than 80,000 emergency room visits annually, while an estimated hundreds of thousands are affected by CRSwNP
- Approval is based on data from the SWIFT and ANCHOR phase III trials, which demonstrated sustained efficacy with a twice-yearly dosing regimen for depemokimab versus placebo.
- Phase III trials showed Exdensur reduced asthma exacerbations, including those requiring hospitalization and/or emergency department visits and improved nasal polyp size and obstruction for CRSwNP patients.
MISSISSAUGA, ON, June 2, 2026 /CNW/ - GSK announced today that Health Canada has approved Exdensur (depemokimab) for two indications:
- As an add-on maintenance treatment in adults and adolescents 12 years and older with severe asthma characterized by an eosinophilic phenotype and inadequately controlled by medium- to high-dose inhaled corticosteroids (ICS) plus another asthma controller.
- As an add-on maintenance treatment with intranasal corticosteroids in adults with severe chronic rhinosinusitis with nasal polyps (CRSwNP) inadequately controlled by systemic corticosteroids and/or surgery.
The approval is based on data from the positive SWIFT and ANCHOR phase III trials. In the SWIFT-1 and SWIFT-2 trials, depemokimab demonstrated a significant reduction in asthma exacerbation rate versus placebo in patients with severe asthma characterized by an eosinophilic phenotype. Depemokimab additionally reduced the number of asthma exacerbations requiring hospitalization and/or emergency department visits versus placebo.1
In the ANCHOR-1 and ANCHOR-2 trials, depemokimab demonstrated significant reductions in nasal polyp size and nasal obstruction versus placebo in patients with chronic rhinosinusitis with nasal polyps.2,3 Across the SWIFT and ANCHOR clinical trials, depemokimab was well-tolerated, with patients experiencing a similar rate and severity of side effects as those receiving placebo.1,4
Michelle Horn, VP & Country Medical Director, GSK Canada, said: "Today's approval of Exdensur by Health Canada is a meaningful milestone for Canadian patients living with severe asthma and/or chronic rhinosinusitis with nasal polyps. With its unique long-acting profile and twice-yearly dosing, Exdensur offers a differentiated treatment option that has the potential to improve disease management and patient outcomes, bringing innovative solutions to address unmet needs in respiratory diseases."
Jeffrey Beach, President & CEO, Asthma Canada, said: "For Canadians struggling with severe asthma and CRSwNP, the approval of Exdensur is truly welcome news. This new treatment, with its unique dosing schedule, represents a meaningful innovation in how these conditions can be managed. While this approval is a vital first step, our priority remains advocating for timely and equitable access, so that this promising therapy can genuinely help to improve the lives of those who need it."
In Canada, more than 4.7 million people are currently affected by asthma, a chronic and sometimes debilitating condition.5 Many Canadian asthmatics continue to experience symptoms such as difficulty breathing and chest tightness, despite treatment with high-dose inhaled corticosteroids plus a second controller.6,7
People with CRSwNP experience symptoms such as nasal obstruction, loss of smell, facial pain, sleep disturbance, infections and nasal discharge that can significantly affect their emotional and physical well-being.8,9,10,11 The impact of CRSwNP on overall quality of life has been reported to be comparable with other chronic diseases such as COPD, asthma, and diabetes.9
Depemokimab is a long-acting monoclonal antibody that targets human interleukin-5 (IL-5), a key cytokine (protein) involved in eosinophilic inflammation, which is an underlying driver in many diseases present in the majority of patients with difficult-to-treat asthma and up to 85% of people with CRSwNP.8,9,10,11,12 Exdensur's extended half-life, high-binding affinity and specificity support its dosing regimen of one injection every six months (26 weeks).1,2,3
About the SWIFT phase III trials
The SWIFT-1 and SWIFT-2 clinical trials assessed the efficacy and safety of depemokimab adjunctive therapy in 382 and 380 participants with severe asthma who were randomized to receive depemokimab or a placebo respectively, in addition to their standard of care (SOC) treatment with medium to high-dose inhaled corticosteroids plus at least one additional controller. The full analysis set in SWIFT-1 included 250 patients in the depemokimab plus SOC arm and 132 in the placebo plus SOC arm; in SWIFT-2, 252 patients were included in the depemokimab plus SOC arm and 128 in the placebo plus SOC arm.1
Results from the SWIFT trials were presented at the 2024 European Respiratory Society International Conference and published in the New England Journal of Medicine.1,15
About the ANCHOR phase III trials
ANCHOR-1 included 143 patients in the depemokimab plus SOC arm and 128 in the placebo plus SOC arm; in ANCHOR-2, 129 patients were included in the depemokimab plus SOC arm and 128 in the placebo plus SOC arm. All 528 patients had inadequately controlled CRSwNP, including nasal polyps in both nasal cavities (an endoscopic bilateral NPS ≥5), and had either undergone previous surgery for CRSwNP, had received previous treatment with systemic corticosteroids (SCS) or were intolerant to SCS. Patients received depemokimab or placebo at six-monthly intervals (26 weeks) in addition to SOC (maintenance intranasal corticosteroids).2
Results from the ANCHOR trials were presented at the 2025 American Academy of Allergy, Asthma and Immunology (AAAAI) and World Allergy Organization (WAO) Joint Congress and published in The Lancet.4,16
About severe asthma
Severe asthma is defined as asthma that requires treatment with medium- to high-dose inhaled corticosteroids plus a second therapy (i.e., systemic corticosteroid or biologic) to prevent it from becoming uncontrolled, or which remains uncontrolled despite therapy.13 Type 2 inflammation is the underlying pathology in more than 80% of patients with severe asthma, in which patients exhibit elevated levels of eosinophils (a type of white blood cell).13
About CRSwNP
CRSwNP is caused by inflammation of the nasal lining that can lead to soft tissue growths, known as nasal polyps.9,12 People with CRSwNP experience debilitating symptoms such as nasal obstruction, loss of smell, facial pain, sleep disturbance, infections and nasal discharge that can significantly affect their emotional and physical well-being.9,12 Similar to asthma, the majority of cases of CRSwNP (85%) are driven by chronic type 2 inflammation, which is strongly associated with comorbidities, more severe disease, recurring symptoms and tissue remodelling.8,9,10,11,12,14
About Exdensur (depemokimab)
Exdensur is the first and only long-acting biologic being developed for certain inflammatory diseases characterized by raised eosinophils. It combines high interleukin-5 (IL-5) binding affinity and high specificity with an extended half-life to enable twice-yearly dosing.1,4
Please consult the Exdensur product monograph at https://gsk.ca/EXDENSUR/pm for complete safety information. The product monograph is also available by calling 1-800-387-7374.
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 of modifying the underlying disease dysfunction and preventing 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 www.gsk.ca.
Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the "Risk Factors" section in GSK's Annual Report on Form 20-F for 2025, and GSK's Q1 Results for 2026.
References |
1. Jackson DJ, et al. Six Monthly Depemokimab in Severe Asthma With an Eosinophilic Phenotype. NEJM. Published on September 9 at NEJM.org. |
2. ClinicalTrials.gov. Efficacy and Safety of Depemokimab (GSK3511294) in Participants With Chronic Rhinosinusitis With Nasal Polyps (ANCHOR-1) Available at: https://clinicaltrials.gov/study/NCT05274750. Accessed February 2025. |
3. ClinicalTrials.gov. Efficacy and Safety of Depemokimab (GSK3511294) in Participants With Chronic Rhinosinusitis With Nasal Polyps (ANCHOR-2) Available at: https://clinicaltrials.gov/study/NCT05281523. Accessed February 2025. |
4. Gevaert P, et al. Efficacy and safety of twice per year depemokimab in chronic rhinosinusitis with nasal polyps (ANCHOR-1 and ANCHOR-2): phase III, randomised, double-blind, parallel trials. The Lancet. Published on February 28 at thelancet.com. |
5. Public Health Agency of Canada. (2024). Canadian Chronic Disease Surveillance System (CCDSS) Data Tool. Retrieved from https://health-infobase.canada.ca/ccdss/data-tool/. |
6. Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention, 2024. Updated May 2024. Available at: https://ginasthma.org/. Accessed February 2025. |
7. World Health Organisation. Asthma Key Facts. Available at: https://www.who.int/news-room/fact-sheets/detail/asthma. Accessed February 2025. |
8. Laidlaw TM, et al. Chronic Rhinosinusitis with Nasal Polyps and Asthma. J. Allergy Clin. Immunol. 2001;9(3):1133-1141. |
9. Bachert C, et al. Burden of Disease in Chronic Rhinosinusitis with Nasal Polyps. J Asthma Allergy. 2021;b 11;14:127-134. |
10. De Corso E, et al. How to manage recurrences after surgery in CRSwNP patients in the biologic era: a narrative review. Acta Otorhinolaryngol Ital. 2023;43 (Suppl. 1):S3-S13. |
11. Chen S, et al. Systematic literature review of the epidemiology and clinical burden of chronic rhinosinusitis with nasal polyposis. Curr Med Res Opin. 2020;36(11):1897-1911. |
12. Bachert C, et al. EUFOREA expert board meeting on uncontrolled severe chronic rhinosinusitis with nasal polyps (CRSwNP) and biologics: Definitions and management. J Allergy Clin Immunol. 2021;147(1):29-36. |
13. Heaney L, et al. Eosinophilic and Noneosinophilic Asthma: An Expert Consensus Framework to Characterize Phenotypes in a Global Real-Life Severe Asthma Cohort. Chest. 2021;160(3):814-830. |
14. Bernstein JA. Use of patient-reported outcome measures and inflammatory biomarkers to differentiate chronic rhinosinusitis with nasal polyp endotypes: Is it feasible? Ann Allergy Asthma Immunol. 2023 Apr;130(4):409-410. doi: 10.1016/j.anai.2023.01.004. PMID: 37005049. |
15. Jackson, D, et al. "Late breaking abstract - depemokimab efficacy/safety in patients with asthma on medium/high-dose ICS: The phase IIIA randomised SWIFT-1/2 studies." European Respiratory Journal 2024, vol. 64, no. 68, 14 Sept. 2024, https://doi.org/10.1183/13993003.congress-2024.rct3718. |
16. Han, J, et al. Efficacy and Safety of Twice-Yearly Depemokimab in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP): The Phase III Randomized, Double-Blind, Placebo-Controlled Replicate ANCHOR-1/2 Trials. Journal of Allergy and Clinical Immunology, Volume 155, Issue 2, AB443. www.jacionline.org |
SOURCE GlaxoSmithKline Inc.
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