GSK announced today that Health Canada has approved Exdensur (depemokimab) for two indications: as an add-on maintenance treatment in adults and adolescents aged 12 and older with severe asthma characterized by an eosinophilic phenotype, and as an add-on maintenance treatment with intranasal corticosteroids in adults with severe chronic rhinosinusitis with nasal polyps (CRSwNP).
Exdensur is the first and only long-acting biologic with twice-yearly dosing approved in Canada for these conditions. 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.
Clinical Trial Data
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.
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. 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.
Expert Comments
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. 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.
