FDA
Exdensur OK’d for severe eosinophilic asthma
Brand name: Exdensur
Generic name: depemokimab-ulaa
Manufacturer: GSK
Approval date: December 16, 2025
FDA has approved Exdensur (depemokimab-ulaa), an IL-5 antagonist, as an add-on maintenance treatment of severe asthma characterized by an eosinophilic phenotype in adult and pediatric patients ≥12 years of age.
Efficacy
Approval was based on data from the phase 3 SWIFT-1 (NCT04719832) and SWIFT-2 (NCT04718103) trials. The trials enrolled adult and pediatric patients ≥12 years of age with asthma characterized by an eosinophilic phenotype, defined as a blood eosinophil count ≥150 cells/mcL at screening or ≥300 cells/mcL documented in the year prior to study entry. Patients were required to have 2 or more asthma exacerbations requiring treatment with systemic corticosteroids (SCS) in the prior year while on background asthma therapy consisting of a medium- to high-dose ICS plus at least one additional asthma controller with or without maintenance oral corticosteroids (OCS). Patients were also required to have reduced lung function at baseline (pre-bronchodilator FEV1 <80% predicted normal in adults; FEV1 <90% or FEV1 to forced vital capacity ratio ><0.8 in pediatric patients aged 12 years and ><90% or FEV1 to FVC ratio <0.8 in pediatric patients ≥12 years of age). Patients were enrolled without requiring a minimum baseline Asthma Control Questionnaire-5 (ACQ-5) score. In these trials, Exdensur 100 mg was administered SC once every 6 months for a total of 2 doses in addition to background asthma therapy. The efficacy population consisted of 762 patients who received at least 1 dose of Exdensur 100 mg or placebo in SWIFT-1 (N = 382) and SWIFT-2 (N = 380).
Treatment with depemokimab resulted in a significant 58% and 48% reduction in the rate of annualized asthma exacerbations over 52 weeks from SWIFT-1 and SWIFT-2, respectively.
In a secondary endpoint from SWIFT-1 and SWIFT-2, patients treated with depemokimab experienced numerically fewer exacerbations requiring hospitalization and/or emergency department visits (1% and 4%) compared with placebo (8% and 10%), respectively. A pre-specified pooled analysis of the two trials showed there was a 72% reduction in the annualized rate of clinically significant exacerbations requiring hospitalization and/or ED visits over 52 weeks for depemokimab compared with placebo.
Safety
Across the SWIFT trials, depemokimab was well-tolerated, with patients experiencing a similar rate and severity of adverse effects as those receiving placebo.
The most common adverse reactions reported with treatment were upper respiratory tract infection, allergic rhinitis, influenza, arthralgia, and pharyngitis.
Recommended dose
The recommended dosage of Exdensur is 100 mg once every 6 months administered SC by an HCP.
Sources:
Exdensur (depemokimab) approved by US FDA for the treatment of severe asthma. [News release]. 2025. https://www.gsk.com/en-gb/media/press-releases/exdensur-depemokimab-approved-by-us-fda-for-the-treatment-of-severe-asthma/
Exdensur (depemokimab-ulaa) [package insert]. GSK. https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Exdensur/pdf/EXDENSUR-PI-PIL.PDF Revised December 2025. Accessed December 21, 2025.