Health Canada approved Exdensur (depemokimab) as a twice-yearly treatment for severe asthma and chronic rhinosinusitis with nasal polyps on June 2, 2026. The clearance relies on SWIFT and ANCHOR phase III trials, offering patients a long-acting monoclonal antibody targeting interleukin-5 to manage uncontrolled eosinophilic inflammation and polyp size.
Health Canada has cleared a new twice-yearly injectable biologic for respiratory and sinus conditions announced by GSK on June 2, 2026. The treatment, known as Exdensur, provides an extended half-life formulation of depemokimab designed to manage severe eosinophilic asthma and chronic rhinosinusitis with nasal polyps (CRSwNP) with just two doses per year.
Health Canada Approvals for Exdensur in Asthma and CRSwNP Care
The regulatory nod covers two specific indications for adult and adolescent patients. For severe asthma characterized by an eosinophilic phenotype, the drug functions as an add-on maintenance treatment for individuals 12 years and older whose condition remains inadequately controlled by medium- to high-dose inhaled corticosteroids combined with another controller medication. For chronic rhinosinusitis with nasal polyps, it acts as an add-on maintenance treatment alongside intranasal corticosteroids for adults inadequately controlled by systemic steroids or surgery.
Behind the clinical decision are data from the SWIFT and ANCHOR phase III trials. The trials also showed decreases in exacerbations requiring emergency department visits or hospitalization. Meanwhile, the ANCHOR trials demonstrated measurable reductions in nasal polyp size and nasal obstruction.
“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.”
Michelle Horn, VP & Country Medical Director, GSK Canada
The Burden of Respiratory Disease and Interleukin-5 Targeting
The physical and emotional weight of these conditions remains substantial across the country. In Canada, more than 4.7 million people live with asthma, and approximately half of those patients remain uncontrolled according to published figures showing over 80,000 emergency room visits annually driven by asthma attacks. Patients dealing with CRSwNP experience persistent nasal obstruction, loss of smell, facial pain, and sleep disruptions that match the quality-of-life impact seen in chronic illnesses like diabetes and COPD.
“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.”
Jeffrey Beach, President & CEO, Asthma Canada
Broader Landscape of Biologic Treatments for Nasal Polyps
The arrival of new therapeutic options coincides with a growing clinical focus on how chronic rhinosinusitis interacts with overall neurological and physical well-being. Academic reviews note that up to 33% of allergic rhinitis patients experience sleep disorders, which correlate with heightened risks of anxiety and depression as outlined in research examining nose-brain communication and inflammatory pathways.
Comparative analyses of biologic therapies continue to evolve within the allergy and immunology sector. Data presented at the American College of Allergy, Asthma & Immunology Annual Scientific Meeting evaluated indirect treatment comparisons across major trials like WAYPOINT, SINUS-52, and SYNAPSE according to findings detailed by medical presenters.
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