Exdensur (depemokimab-ulaa) / GSK - LARVOL DELTA

Dose tapering and treatment de-escalation of biologic therapies in chronic rhinosinusitis with nasal polyps: a narrative review. (PubMed, Front Surg) - "Although dupilumab, omalizumab, mepolizumab, benralizumab, tezepelumab, depemokimab, and stapokibart have demonstrated substantial clinical efficacy, the optimal duration and maintenance strategy for biologic therapy remain uncertain...However, standardized tapering protocols and high-quality randomized controlled trials are required before routine implementation. Future research should focus on biomarker-guided patient selection, long-term clinical outcomes, and the cost-effectiveness of biologic dose optimization."

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

Association Between Biologic Therapy and Ocular Adverse Events in Chronic Rhinosinusitis with Nasal Polyps (AAO-HNSF 2026) - "Biologics included dupilumab, omalizumab, mepolizumab, benralizumab, tezepelumab, and depemokimab. Biologic therapy for CRSwNP was associated with increased risk of conjunctivitis, glaucoma, keratitis, and blurred vision, with a borderline increase in ocular irritation, while blepharitis and eyelid rosacea were not significant. These findings support counseling and symptom monitoring, and highlight the need for further mechanistic study and drug-specific risk stratification."

Adverse events • Chronic Rhinosinusitis With Nasal Polyps • Conjunctivitis • Dry Eye Disease • Glaucoma • Immunology • Keratitis • Nasal Polyps • Ocular Infections • Ocular Inflammation • Ophthalmology • Otorhinolaryngology • Respiratory Diseases • Rosacea • Sinusitis

Efficacy and Predictors of Response to Biologic Therapy and Endoscopic Sinus Surgery in Patients With Nasal Polyps: A Systematic Review. (PubMed, Int Forum Allergy Rhinol) - "ESS and biologics provide clinically meaningful benefit. Among biologics, dupilumab and tezepelumab demonstrated the largest effect sizes, though cross-trial differences in baseline severity, follow-up, and comparators limit indirect comparisons. Head-to-head trials and standardized subgroup analyses are needed to guide treatment selection."

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

Real-World Effectiveness of Depemokimab in Allergic Bronchopulmonary Aspergillosis With Severe Eosinophilic Asthma (clinicaltrials.gov) - P=N/A | N=10 | Not yet recruiting | Sponsor: Qianfoshan Hospital

New trial • Real-world evidence • Allergic Bronchopulmonary Aspergillosis • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Late Breaking Abstract - Depemokimab provides early and sustained improvement in loss of smell in chronic rhinosinusitis with nasal polyps (CRSwNP) patients meeting POLINA 2.0 criteria: subanalysis of the randomized phase 3 ANCHOR-1/2 trials (ERS 2026) - P3 | "Depemokimab administered every 6 months provided early and sustained improvements in LoS in patients meeting the POLINA criteria. Funding: GSK (217095/218079; NCT05274750/NCT05281523)."

Clinical • Late-breaking abstract • P3 data • Asthma • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis • IL5

Twice-yearly depemokimab maintains clinically meaningful response over 2 years in patients with asthma and comorbid chronic rhinosinusitis with nasal polyps: Responder analysis of the integrated SWIFT/AGILE studies (ERS 2026) - P3 | "Patients with T2 asthma and CRSwNP had a sustained clinically meaningful response to depemokimab over 2 years. Funding: GSK (NCT04719832/NCT04718103/NCT05243680)"

Clinical • Asthma • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis • IL5

Twice-yearly depemokimab maintains exacerbation reduction and clinical remission over 2 years in patients with asthma, regardless of baseline asthma duration: SWIFT/AGILE integrated analysis (ERS 2026) - P3 | "Twice-yearly depemokimab maintained efficacy over 2 years across asthma duration subgroups. Funding: GSK (SWIFT-1/-2: 206713/213744,NCT04719832/NCT04718103; AGILE: 212895,NCT05243680)"

Clinical • Asthma • Immunology • Respiratory Diseases • IL5

Twice-yearly depemokimab demonstrates early and sustained improvements in peak expiratory flow and daily asthma symptoms in patients with uncontrolled asthma over 52 weeks in SWIFT-1/-2 (ERS 2026) - P3 | "Twice-yearly depemokimab showed early and sustained improvements in PEF and trends of reduced rescue medication use in patients with uncontrolled asthma in SWIFT-1/-2. Funding: GSK (SWIFT-1/-2: 206713/213744,NCT04719832/NCT04718103)"

Clinical • Asthma • Immunology • Respiratory Diseases • IL5

Shaping proactive asthma care: Early biologic intervention trial landscape and insights from the MODIFY study with depemokimab (ERS 2026) - "While there is growing interest in early intervention in asthma, the definition of this population varies broadly, highlighting the value of innovative patient identification using dual T2 biomarkers. Targeting T2 inflammation with early biologic therapy before irreversible progression occurs has the potential to stabilise disease trajectories, improving long‑term outcomes and possibly leading to remission. Funding: GSK (222926; EU CT# 2025-524463-20)"

Asthma • Immunology • Inflammation • Respiratory Diseases

STRIDE-A: A validated self-controlled study aligned with reimbursement decisions and patient priorities to evaluate depemokimab outcomes in patients with type 2 asthma in the real world (ERS 2026) - "The study design of STRIDE-A, endorsed by patients, meets existing data gaps and has objectives consistent with key HTA decision drivers. Funding: GSK (214579)."

Clinical • Real-world • Real-world evidence • Reimbursement • US reimbursement • Asthma • Immunology • Respiratory Diseases

Twice-yearly depemokimab improved symptoms and HRQoL in patients with baseline SNOT-22 score ≥40: Data from ANCHOR-1/-2 (ERS 2026) - P3 | "Twice-yearly depemokimab reduced sinonasal symptom burden and improved HRQoL, including sleep and fatigue, in patients with CRSwNP and highly uncontrolled disease. Funding: GSK(217095/218079; NCT05281523/NCT05274750)"

Clinical • Chronic Rhinosinusitis With Nasal Polyps

Twice-yearly depemokimab maintains clinically meaningful response over 2 years in patients with uncontrolled asthma symptoms at baseline: Responder analysis of the integrated SWIFT/AGILE studies (ERS 2026) - P3 | "A sustained and consistent clinically meaningful response to depemokimab was observed over 2 years in patients with uncontrolled asthma symptoms at baseline. Funding: GSK (NCT04719832/NCT04718103/NCT05243680)"

Clinical • Asthma • Immunology • Respiratory Diseases • IL5

TTWICE-YEARLY DEPEMOKIMAB IS ASSOCIATED WITH EARLY AND SUSTAINED IMPROVEMENTS IN QUALITY-OF-LIFE DOMAINS IN PATIENTS WITH UNCONTROLLED TYPE 2 ASTHMA IN SWIFT-1/-2 (CHEST 2026) - No abstract available

Clinical • HEOR • Asthma • Immunology • Respiratory Diseases

A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of depemokimab for this indication compared with the current standard of care, on the basis of the proposed price relative to currently available therapies. [For severe chronic rhinosinusitis with nasal polyps] (National Centre for Pharmacoeconomics, Ireland)

HEOR • Chronic Rhinosinusitis With Nasal Polyps • Immunology

Efficacy and Safety of Depemokimab Monotherapy Without Concomitant Use of Intranasal Corticosteroids (INCS) in Japanese Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) (clinicaltrials.gov) - P4 | N=28 | Recruiting | Sponsor: GlaxoSmithKline | Not yet recruiting ➔ Recruiting

Enrollment open • Monotherapy • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis

depemokimab (Exdensur) is not recommended for use within NHSScotland (Scottish Medicines Consortium) - "Indication under review: add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP) for whom therapy with systemic corticosteroids and/or surgery do not provide adequate control. The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. As a result, we cannot recommend its use within NHSScotland."

Reimbursement • Chronic Rhinosinusitis With Nasal Polyps • Immunology

DESTINY: Depemokimab in Participants With Hypereosinophilic Syndrome, Efficacy, and Safety Trial (clinicaltrials.gov) - P3 | N=109 | Recruiting | Sponsor: GlaxoSmithKline | Trial completion date: Jul 2032 ➔ Nov 2027 | Trial primary completion date: Dec 2028 ➔ Nov 2027

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

Perioperative Use of Biologics in Patients with Chronic Rhinosinusitis with Nasal Polyps: What Is the Evidence? (PubMed, J Allergy Clin Immunol Pract) - "Among biological treatments, dupilumab has the most extensive perioperative and postoperative human evidence and no clear major operative-harm signal, although dedicated healing endpoints remain limited. Omalizumab provides supportive postoperative disease-control data, but healing inference remains indirect. Mepolizumab offers genuine perioperative exposure, with reassuring but incomplete healing-specific evidence. Tezepelumab and depemokimab have CRSwNP efficacy data but no evidence directly informing perioperative use around ESS. Current evidence cannot justify routine interruption of all biologics, default postoperative use for all patients, or class-wide equivalence. Agent-specific randomized studies and registries anchored in SoC/AMT are needed to define perioperative safety, efficacy, timing, and remucosalization-specific outcomes."

Journal • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis

GLIDE: A Study of Depemokimab in Participants of 6 to 11 Years of Age (clinicaltrials.gov) - P3 | N=34 | Recruiting | Sponsor: GlaxoSmithKline | Not yet recruiting ➔ Recruiting | Trial completion date: Mar 2029 ➔ Nov 2028 | Trial primary completion date: Mar 2029 ➔ Mar 2027

Enrollment open • Trial completion date • Trial primary completion date • Asthma • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases

Long‑acting asthma drug Exdensur gains reimbursement in Sweden (Life Science Nordic)

Reimbursement • Asthma • Immunology

Biologic therapies targeting type 2 inflammation in NSAID-exacerbated respiratory disease. (PubMed, Front Immunol) - "In this review, we summarize current evidence on the efficacy and mechanisms of action of approved biologic therapies, including omalizumab, anti-IL-5/IL-5Rα agents (mepolizumab, reslizumab, depemokimab, benralizumab), dupilumab and tezepelumab, with a particular focus on their effects on sinonasal disease, asthma control, aspirin tolerance, and patient-reported outcomes. We further discuss emerging concepts of personalized and integrated treatment strategies combining biologics, endoscopic sinus surgery, and aspirin desensitization. Finally, we highlight unmet needs, potential biomarkers and future research directions aimed at optimizing treatment selection and improving long-term disease control in N-ERD."

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

Depemokimab-ulaa: A Long-Acting Interleukin-5 Inhibitor. (PubMed, Ann Pharmacother) - "Depemokimab-ulaa's twice-yearly dosing offers a convenient alternative to other anti-IL-5 therapies as add-on treatment for severe eosinophilic asthma."

Journal • Review • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases • IL5

The Therapeutic Goods Administration (TGA) has registered Exdensur (depemokimab), a new add-on maintenance treatment for severe eosinophilic asthma, GSK Australia announced today. (Retail Pharmacy Magazine) - "The medicine is approved for patients aged 12 years and older with type 2 inflammation characterised by an eosinophilic phenotype who remain inadequately controlled on medium- to high-dose inhaled corticosteroids plus another asthma controller....Results from the phase III SWIFT trials showed a 54% reduction in annualised asthma exacerbations among patients receiving depemokimad compared with placebo over 52 weeks."

Approval • Asthma • Immunology

Population Pharmacokinetics and Pharmacodynamics of Depemokimab in People with Asthma and Chronic Rhinosinusitis with Nasal Polyps. (PubMed, J Clin Pharmacol) - P1, P3 | "PK/PD modeling showed that single-dose depemokimab 100 mg provides durable BEC reduction throughout a 26-week dosing interval, suggesting sustained suppression of IL-5 activity. These data support twice-yearly recommended dosing for depemokimab 100 mg, with no dose adjustments required based on intrinsic or extrinsic factors."

Clinical • Journal • PK/PD data • Asthma • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Inflammation • Nasal Polyps • Otorhinolaryngology • Pulmonary Disease • Respiratory Diseases • Sinusitis • IL5

DESTINY: Depemokimab in Participants With Hypereosinophilic Syndrome, Efficacy, and Safety Trial (clinicaltrials.gov) - P3 | N=123 | Recruiting | Sponsor: GlaxoSmithKline | Trial completion date: Dec 2028 ➔ Jul 2032

Trial completion date • Hypereosinophilic Syndrome • Immunology