Depemokimab

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 pro 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 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 . 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: Accessed February 2025. 3. ClinicalTrials.gov. Efficacy and Safety of Depemokimab (GSK3511294) in Participants With Chronic Rhinosinusitis With Nasal Polyps (ANCHOR-2) Available at: 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 6. Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention, 2024. Updated May 2024. Available at: Accessed February 2025. 7. World Health Organisation. Asthma Key Facts. Available at: 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, 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. SOURCE GlaxoSmithKline Inc.

In Luke Miels' first quarter as CEO, GSK's Q1 revenue of £7.6 billion marked a 5% increase year over year at constant exchange rates. In GSK’s first quarter under Luke Miels as CEO, the company’s flagship shingles vaccine, Shingrix, set a new quarterly sales record, while its closely watched asthma launch, Exdensur, showed “early signals” of commercial progress despite a recent trial flop.Sales of Shingrix in the U.S. bounced back from a 17% decline in full-year 2025 to reach 12% growth in the first quarter at constant exchange rates, fueled by inventory build related to the launch of a new, easier-to-use prefilled syringe.A boost from the U.S. market, plus strong demand in Europe, lifted Shingrix’s global Q1 sales to 1.03 billion pound sterling ($1.39 billion), setting a new quarterly record, Nina Mojas, GSK’s president, global products strategy, said Wednesday on an investor call.As the entire vaccine industry grapples with a hostile U.S. policy environment, Shingrix’s surge comes as a surprise. The turnover beat Wall Street’s expectations by 20%.In the U.S., cumulative immunizations for shingles grew 3.5 percentage points year over year and reached 45% among eligible adults, according to Miels.“If you look at the remaining effort, there’s about 70 million people above 50 who remain unvaccinated. About a third of them have intent to get vaccinated,” Miels said on the call, citing market research. “We’re concentrating on the comorbid subpopulation that are more motivated, and their doctors and pharmacists are more motivated to do that.” Meanwhile, demand in China also appears to be improving as the number of administered doses increases, although this dynamic is not being reflected in GSK’s sales numbers for at least the majority of the year because the doses are coming from existing stockpiles at its partner, Chongqing Zhifei Biological Products, Mojas said. The market for self-paid vaccines has shrunk in China in recent years, impacting major products such as Shingrix and Merck & Co.’s HPV blockbuster Gardasil, which is also distributed by Zhifei.For the rest of the year, however, Mojas cautioned about difficult year-over-year comparisons for the vaccine in Europe and Japan.“Further penetration opportunities remain with around 11% of the eligible population immunized in our top 10 markets outside the U.S.,” she said.While Shingrix drove GSK’s Q1 sales growth, numbers from the respiratory syncytial virus vaccine Arexvy do not look so rosy. The shot’s sales dropped 18% to 65 million pounds sterling with low out-of-season uptake, missing analysts’ consensus by 13%, as U.S. sales continued to decline amid slower market demand. Launch progress On Wednesday’s call, GSK’s management touted the launch momentum of several newer products. Among them, twice-yearly IL-5 drug Exdensur is one of the most important rollouts, with its peak annual sales estimated at about 3 billion pounds sterling by GSK across several respiratory diseases. Approved by the FDA to treat severe asthma in December, Exdensur only brought in 11 million pounds sterling in Q1 sales. Mojas noted that access to the drug in the U.S. is currently limited to about 20% of commercial patients ahead of the assignment of a permanent J-code for reimbursement, which is expected in July. “Unaided awareness is ahead of benchmarks and intent to use is nicely at benchmark,” Miels said of Exdensur. “And the main driver is questions around access, which is what we expect, particularly when you’re buying a six-monthly treatment.”To convince investors that Exdensur and its long-acting dosing represent “a key value driver,” Mojas noted that 65% of patients discontinued their short-acting biologic in the first 12 months. In its early launch days, about 70% of Exdensur users are coming from other biologics, she noted. Biologic compliance is a main reason for discontinuation, as some patients end up switching back to inhaled medicines, Mojas said. However, GSK recently hit a snag with its plan to convince patients that they can switch from an existing short-acting biologics to Exdensur with similar benefits. The phase 3a Nimble trial, which compared Exdensur with GSK’s own monthly Nucala or AstraZeneca’s bimonthly Fasenra, failed to meet statistical non-inferiority. Annualized rates of clinically significant exacerbations over 52 weeks were 0.57 with the GSK drug, versus 0.49 for the comparator arm. While the rate ratio was 1.16, the upper bound of the 95% confidence interval reached 1.38, which exceeded the predefined non-inferiority bar of 1.28, leading the trial to miss its main endpoint. Because Nimble was a well-controlled study, the general exacerbation rate was low, GSK’s R&D chief Tony Wood, Ph.D., said on the earnings call. The absolute difference in annual exacerbation rates was 0.08 between the two arms, meaning that a patient on therapy would need 12.5 years to realize a single additional exacerbation, he noted.“You put that into the context of the beneficial compliance that’s associated with the longer-acting agent, I think you have the importance of [Exdensur] as a long-acting agent in that population,” Wood said.In a well-controlled study, patients are closely followed and treatment adherence is typically better compared with real-world experience. Mojas also pointed out that about 30% of asthma patients are taking a biologic. She suggested that Exdensur could capture some of the biologic-naïve patients with its convenience edge once it gets the J-code. Exdensur is undergoing three phase 3 trials—Endura-1, -2 and Vigilant—in moderate to severe chronic obstructive pulmonary disease, an indication that fueled Nucala’s 12% growth at constant exchange rates to 484 million pound sterling in Q1. All told, GSK’s Q1 haul of 7.6 billion marked a 5% increase year over year at constant currencies, meeting analysts’ consensus. The British pharma affirmed its full-year 2026 guidance, including sales increase of between 3% to 5%.