Exdensur (depemokimab-ulaa) / GSK - LARVOL DELTA

Twice-Yearly Depemokimab Improved Nasal Polyp Burden and Nasal Obstruction in Chinese Patients with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP): Subpopulation Analysis of Phase 3 ANCHOR-1/2 Trials (AAAAI 2026) - P3 | "Depemokimab showed improvements from baseline versus placebo in total endoscopic NPS at Week 52 (treatment difference [95% CI]: ANCHOR-1/2, -0.4 [-1.8, 1.1]/-0.7 [-2.0, 0.6]; integrated, -0.5 [-1.4, 0.5]) and mean nasal obstruction VRS score over Weeks 49–52 (treatment difference [95% CI]: ANCHOR-1/2, -0.03 [-0.57, 0.51]/-0.23 [-0.72, 0.25]; integrated, -0.18 [-0.60, 0.25]). In integrated Conclusions Twice-yearly depemokimab improved co-primary endpoints versus placebo and was well-tolerated in Chinese individuals with CRSwNP, consistent with global findings."

Clinical • P3 data • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Inflammation • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis

Twice-Yearly Depemokimab Delivers Clinically Meaningful Improvements in Patients With CRSwNP With Features of T2 inflammation and Disease Recurrence Following Surgery: Post Hoc Pooled Analysis of ANCHOR-1/-2 (AAAAI 2026) - "Depemokimab demonstrated higher responder rates versus placebo for NO VRS (46% vs 21%; OR [95% CI]: 2.82 [1.37, 5.78]; p=0.006), LoS VRS (29% vs 15%; OR: 2.35 [0.99, 5.60]; p=0.054), SNOT-22 (65% vs 43%; OR: 2.25 [1.15, 4.39]; p=0.019), and NP (41% vs 25%; OR: 2.04 [0.99, 4.20]; p=0.053) scores, and lower rates for rescue intervention use (19% vs 37%; OR: 0.34 [0.16, 0.75]; p=0.008). Conclusions Despite limited patient numbers, twice-yearly depemokimab led to clinically meaningful improvements in symptoms and QoL while reducing rescue intervention needs in patients with CRSwNP recurrence, offering a promising treatment option with reduced dosing frequency."

Late-breaking abstract • Retrospective data • Surgery • Chronic Rhinosinusitis With Nasal Polyps • Inflammation • IL5

Blood Eosinophil Counts Are Positively Correlated with T2 Cytokine (IL-4, IL-5, and IL-13) Levels in Patients with CRSwNP: Pooled Post Hoc Analysis of Data from ANCHOR-1/-2 Studies (AAAAI 2026) - P1 | "This post hoc analysis assessed the relationship between BEC and T2 cytokine levels in patients with CRSwNP from the Phase III ANCHOR-1/-2 trials of depemokimab, the first ultra-long-acting biologic with enhanced IL-5 binding affinity, high Methods Baseline BEC from patients with CRSwNP (N=295; ANCHOR-1/-2) and serum IL-4, IL-5, and IL-13 levels (assessed using MSD S-plex assays) from patients with CRSwNP and non-atopic healthy volunteers (HVs; N=82; GSK ID: 214099/NCT05602025) were measured...In addition, baseline serum IL-4, IL-5, and IL-13 levels were higher in patients with CRSwNP than in HVs (all p<0.0001; CRSwNP vs HVs, median [min,max]fg/mL: IL-4, 15.5 [1.5,185.3], n=286 vs 9.6 [2.1,71.0, n=81[SF1] [SF2]; IL-5, 1696.4 [113.9,27,101.2], n=288 vs 454.0 [114.8,9926.6], n=81; IL-13, 49.9 [8.1,593.7], Conclusions BEC positively and significantly correlated with IL-4, IL-5, and IL-13, highlighting the value of BEC as a T2 inflammation biomarker. These cytokines..."

Clinical • Late-breaking abstract • Retrospective data • Chronic Rhinosinusitis With Nasal Polyps • Inflammation • IL13 • IL4 • IL5

Long-Term Safety and Efficacy of Depemokimab in Patients with Type 2 Asthma: A Single-Arm, Open-Label Extension Study (AGILE) (AAAAI 2026) - P3 | "Efficacy was sustained in patients previously receiving depemokimab, while those switching from placebo experienced notable reductions in exacerbations. These findings support the long-term safety and efficacy of depemokimab in asthma."

Clinical • Asthma • Immunology • Respiratory Diseases • IL5

Depemokimab Improved Nasal Polyp Score, Symptoms and Quality of Life in Patients with CRSwNP Who Had Disease Recurrence Following One Surgery and Indicators of Type 2 Inflammation: Post Hoc Pooled Analysis of ANCHOR-1/2 (AAAAI 2026) - "Results Overall, 154 patients met the eligibility criteria (79 depemokimab/75 placebo). Depemokimab versus placebo significantly improved NPS (LS mean CFB [SE]: -0.6[0.18] versus 0.0[0.19]; treatment difference [95% CI]: -0.6[-1.1,-0.1],p=0.023); NO-VRS score (-0.87[0.099] versus -0.46[0.103]; difference: -0.41[-0.69,-0.13],p=0.006), LoS-VRS score (-0.57[0.093] versus -0.26[0.097]; difference: -0.31[-0.58,-0.05],p=0.022) and total SNOT-22 score (-17.2[3.68] versus -5.8[3.81]; difference: Conclusions Twice-yearly depemokimab versus placebo improved NPS, key symptoms and quality of life in patients with CRSwNP who had one surgery and indicators of T2 inflammation, supporting its potential use in this population commonly considered for biologic therapy."

HEOR • Retrospective data • Surgery • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Inflammation • Nasal Polyps • Otorhinolaryngology • IL5

Comorbid Chronic Rhinosinusitis and Asthma: Shared Risk Factors and Treatment Implications-An EAACI Task Force Report. (PubMed, Allergy) - "It also evaluates current therapeutic strategies such as biologics, aspirin therapy after desensitization (ATAD), and endoscopic sinus surgery (ESS)...Dupilumab, mepolizumab, depemokimab, and omalizumab have emerged as transformative therapies, particularly for patients with severe type 2 inflammation...Itepekimab has shown its effect in asthma and is under investigation for CRSwNP...The report highlights gaps in the literature, such as the lack of head-to-head trials comparing biologics, ATAD, and surgery. Future research should focus on refining treatment algorithms, identifying biomarkers for treatment selection, and assessing long-term outcomes to optimize care for patients with CRS, asthma, and N-ERD."

Journal • Asthma • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Inflammation • Nasal Polyps • Otorhinolaryngology • Pulmonary Disease • Respiratory Diseases • Sinusitis • IL13 • IL5

Exdensur: Regulatory decision in China for severe asthma in H1 2026 (GSK) - Q4 2025 Results: Regulatory decisions in EU/China for chronic rhinosinusitis with nasal polyps in H1 2026; Regulatory decision in US for EGPA in 2027; Acceptance of regulatory submissions in US/EU/China/Japan for EGPA (based on OCEAN trial) in 2027

China approval • China filing • EMA approval • EMA filing • FDA approval • FDA filing • Japan filing • Asthma • Chronic Rhinosinusitis With Nasal Polyps • Eosinophilic Granulomatosis With Polyangiitis • Immunology

CareMed, an independent specialty pharmacy, has been selected as a pharmacy partner by GSK for Exdensur (depemokimab), indicated for the add-on maintenance treatment of severe asthma characterized by an eosinophilic phenotype in adult and pediatric patients aged 12 years and older (GlobeNewswire)

Commercial • Asthma • Immunology

Depemokimab for treating chronic rhinosinusitis with nasal polyps in adults (terminated appraisal) (NICE) - "NICE is unable to make a recommendation on depemokimab (Exdensur) for treating chronic rhinosinusitis with nasal polyps in adults. This is because the company did not provide an evidence submission."

NICE • Chronic Rhinosinusitis With Nasal Polyps

Straight to Phase III: Model-Informed Approach Speeds Depemokimab Clinical Development in Interleukin-5-Driven Diseases. (PubMed, Clin Pharmacol Ther) - "A Bayesian nonlinear mixed effects dose-time response model predicted the depemokimab dose in severe asthma achieving comparable BEC reductions to those observed in mepolizumab (an approved anti-IL-5 biologic) Phase III MUSCA and MENSA trials. Depemokimab 100 mg for severe asthma/CRSwNP and 200 mg for EGPA/HES, administered subcutaneously every 26 weeks, were selected for Phase III trials. MIDD and QDM shortened the depemokimab development program by 2-3 years, emphasizing the potential of this approach for progressing new therapies from Phase I directly to Phase III."

Journal • P3 data • Asthma • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases • IL5

An Open-Label Extension Study of GSK3511294 (Depemokimab) in Participants Who Were Previously Enrolled in 206713 (NCT04719832) or 213744 (NCT04718103) (clinicaltrials.gov) - P3 | N=641 | Completed | Sponsor: GlaxoSmithKline | Active, not recruiting ➔ Completed

Trial completion • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

GSK on Tuesday said Japan’s Ministry of Health, Labour and Welfare approved Exdensur, also known as depemokimab, for patients with bronchial asthma whose symptoms cannot be controlled with existing treatments and for patients with chronic rhinosinusitis with nasal polyps that remains inadequately controlled with standard therapy (Investing.com) - "The decision was based on results from the phase III SWIFT and ANCHOR clinical trial programs. In the SWIFT-1 and SWIFT-2 trials, patients treated with depemokimab experienced fewer asthma attacks over 52 weeks compared with those who received placebo....Results from the ANCHOR-1 and ANCHOR-2 trials showed improvements in patients with chronic rhinosinusitis with nasal polyps."

Japan approval • Asthma • Chronic Rhinosinusitis With Nasal Polyps • Immunology

Safety and Tolerability of Twice-Yearly Depemokimab in Patients with Asthma and Chronic Rhinosinusitis with Nasal Polyps: Pooled Results from SWIFT-1/-2 and ANCHOR-1/-2. (PubMed, Adv Ther) - P3 | "In these studies, twice-yearly depemokimab 100 mg was generally well tolerated by patients with T2 asthma or CRSwNP over the 52-week treatment period, supporting the safety of the first ultra-long-acting biologic for these diseases."

Clinical • Journal • Asthma • Back Pain • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Inflammation • Musculoskeletal Pain • Nasal Polyps • Otorhinolaryngology • Pain • Pulmonary Disease • Respiratory Diseases • Sinusitis

Exdensur (depemokimab) approved by US FDA for the treatment of severe asthma (GSK Press Release) - "The FDA approval of Exdensur is based on data from the SWIFT-1 and SWIFT-2 phase III trials. In these studies, depemokimab demonstrated sustained exacerbation reduction with two doses per year versus placebo, both plus standard of care....Depemokimab recently received...a positive CHMP opinion in Europe, with an approval decision expected in Q1 2026. Regulatory submissions are also under review across the globe, including in China and Japan."

China filing • EMA approval • FDA approval • Japan filing • Asthma • Immunology

The Medicines and Healthcare products Regulatory Agency (MHRA) has today (15 December 2025) approved depemokimab (Exdensur), the first twice-yearly biological medicine for use as an add-on treatment for asthma in adults and adolescents aged 12 years and older, and as an add-on treatment for severe chronic rhinosinusitis with nasal polyps (CRSwNP) in adults. (GOV.UK)

MHRA approval • Asthma • Chronic Rhinosinusitis With Nasal Polyps • Immunology

Exdensur (depemokimab) received a positive opinion from the CHMP for the treatment of a particular type of asthma called severe eosinophilic asthma, and for severe chronic rhinosinusitis with nasal polyps, an inflamed lining of the nose and sinuses with swellings in the nose. (European Medicines Agency)

CHMP • Asthma • Chronic Rhinosinusitis With Nasal Polyps • Immunology

Efficacy and safety of Depemokimab in asthma with eosinophilic phenotype: a systematic review and meta-analysis of randomized controlled trials. (PubMed, BMC Immunol) - "Depemokimab demonstrates promising efficacy in reducing clinically significant exacerbations and improving quality of life measures in patients with severe eosinophilic asthma, with a generally favorable safety profile. However, the current evidence is limited to two trials with relatively short follow-up periods. Further research with larger, more diverse patient populations and extended long-term follow-up is needed to establish the drug's definitive place in therapeutic algorithms and to comprehensively evaluate potential long-term safety concerns before widespread clinical implementation can be recommended."

Journal • Retrospective data • Allergic Rhinitis • Asthma • Back Pain • Immunology • Infectious Disease • Inflammation • Musculoskeletal Pain • Pain • Pneumonia • Pulmonary Disease • Respiratory Diseases • IL5

Twice-yearly depemokimab efficacy is sustained across seasons in patients with asthma: analyses of pooled phase III SWIFT-1/2 studies (BTS WM 2025) - "Reference Celis-Preciado C, et al. European Respiratory Journal 2025 May."

Clinical • P3 data • Asthma • Immunology • Inflammation • Respiratory Diseases

Development of a multi-modal model to predict asthma outcomes using digital monitoring tools (BTS WM 2025) - "The annualised exacerbation rates (95% CI) in the depemokimab arm remained broadly consistent across all four seasons (spring: 0.46 [0.35, 0.61]; summer: 0.47 [0.36, 0.62]; autumn: 0.56 [0.44, 0.71]; winter: 0.57 [0.45, 0.72]; however, in the placebo arm exacerbation rates were, as expected, numerically lower in summer (spring: 1.10 [0.84, 1.43]; summer: 0.78 [0.58, 1.07]; autumn: 1.23 [0.97, 1.56]; winter: 1.30 [1.03, 1.63]) ( figure 1 ). Download figure Open in new tab Download powerpoint Abstract P201 Figure 1 Annualised exacerbation rate reductions in patients receiving depemokimab versus placebo were consistent across spring, autumn and winter, with a lower magnitude of reduction in summer due to reduced exacerbation rates in the placebo group Conclusion Overall, twice-yearly depemokimab demonstrated a sustained clinical benefit for patients with type 2 asthma across all four seasons, regardless of additional exacerbation triggers over the autumn and winter months."

Biomarker • Asthma • Immunology • Inflammation • Respiratory Diseases • IL5

Twice-yearly depemokimab demonstrates efficacy in patients with asthma across baseline medium- and high-dose ICS subgroups: Phase III SWIFT-1/2 studies (BTS WM 2025) - P3 | "Funding GSK (206713/213744; NCT04719832 /NCT04718103). Download figure Open in new tab Download powerpoint Abstract S135 Figure 1 (A) Annualised exacerbation rate and (B) LS mean change from baseline to Week 52 in SGRQ total score in patients receiving depemokimab or placebo stratified by baseline ICS dose (medium/high)"

Clinical • P3 data • Asthma • Immunology • Inflammation • Respiratory Diseases • IL5

Severe asthma patient perceptions and preferences on the frequency of biologic administration; including opinions on upcoming 6 monthly biologic (BTS WM 2025) - "Concerns related to side effects, cost, and appointment accessibility were more frequently associated with monthly treatment. View this table: View inline View popup Download powerpoint Abstract P131 Table 1 Conclusion This study provides a previously unknown insight into severe asthma patient views on their preferred frequency of biologic administration and seems to suggets an appetite for engagement with an upcoming 6-monthly biologic Depemokimab."

Clinical • Asthma • Immunology • Respiratory Diseases

Drop ANCHOR with Depemokimab or sail to the WAYPOINT with Tezepelumab: A Bucher indirect treatment comparison. (PubMed, Ann Allergy Asthma Immunol) - No abstract available

Journal • Chronic Rhinosinusitis With Nasal Polyps

DESTINY: Depemokimab in Participants With Hypereosinophilic Syndrome, Efficacy, and Safety Trial (clinicaltrials.gov) - P3 | N=123 | Recruiting | Sponsor: GlaxoSmithKline | Trial completion date: Nov 2026 ➔ Dec 2028 | Trial primary completion date: Nov 2026 ➔ Dec 2028

Trial completion date • Trial primary completion date • Hypereosinophilic Syndrome • Immunology

VIGILANT: eValuating the Efficacy and Safety of InitiatinG depemokImab earLy therApy iN Chronic Obstructive Pulmonary Disorder (COPD) With Type 2 Inflammation (clinicaltrials.gov) - P3 | N=1196 | Recruiting | Sponsor: GlaxoSmithKline | Not yet recruiting ➔ Recruiting

Enrollment open • Chronic Obstructive Pulmonary Disease • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases

Twice-Yearly Depemokimab Improves Peak Expiratory Flow and Asthma Symptoms (Pharmacy Times) - "The findings indicated that depemokimab was associated with greater improvements in least squares mean change from baseline in morning PEF compared with placebo from week 1 to 2 (18.08 [95% CI, 14.16–22.01] vs 9.07 [95% CI, 3.65–14.48] L/min, respectively), with an overall treatment difference of about 9.02 (95% CI, 2.31–15.72). Of note, improvement was sustained until weeks 51 to 52 (23.66 [95% CI, 17.64–29.67] vs 7.81 [95% CI, 0.54–16.16], respectively), with a treatment difference of about 15.84 (95% CI, 5.54–26.15)."

P3 data • Asthma