FDA Approves Depemokimab-ulaa (Exdensur) for Severe Asthma

The US Food and Drug Administration (FDA) has approved GSK’s depemokimab-ulaa (Exdensur) as an add-on maintenance treatment of severe asthma characterized by an eosinophilic phenotype in adult and pediatric patients ≥ 12 years of age.1

As described in a December 16, 2025, release from the Company, the decision was based on data from the phase 3 SWIFT-1 and SWIFT-2 trials showing sustained exacerbation reduction with 2 doses per year versus placebo, both plus standard of care.1

“Current biologic treatments for asthma are often underutilised and frequent injections can be inconvenient for many patients and lead to inconsistent use. There is clearly an opportunity to provide a longer duration of protection from exacerbations between injections for severe asthma patients that reduces the frequency of doses and may improve overall health care utilisation,” Geoffrey Chupp, MD, Professor of Medicine, Pulmonary, Critical Care and Sleep Medicine, Yale University, said in a statement.1 “Exdensur could empower physicians and patients to potentially achieve their treatment goals with fewer injections.”

Depemokimab-ulaa is the first ultra-long-acting biologic being evaluated for certain respiratory diseases with underlying type 2 inflammation, such as severe asthma. It has been developed with an extended half-life to enable twice-yearly dosing.1

SWIFT-1 and SWIFT-2 assessed the efficacy and safety of depemokimab adjunctive therapy in 382 and 380 participants with severe asthma who were randomly assigned to receive depemokimab or a placebo respectively, in addition to their standard of care treatment with medium to high-dose inhaled corticosteroids plus ≥ 1 additional controller.1,2

The full analysis set in SWIFT-1 included 250 patients in the depemokimab plus standard of care arm and 132 in the placebo plus standard of care arm; in SWIFT-2, 252 patients were included in the depemokimab plus standard of care arm and 128 in the placebo plus standard of care arm.1,2

Results showed treatment with depemokimab resulted in a significant 58% and 48% reduction in the rate of annualised asthma exacerbations (asthma attacks) over 52 weeks from SWIFT-1 and SWIFT-2, respectively (SWIFT-1: Rate ratio, 0.42; 95% CI, 0.30-0.59; P <.001 and SWIFT-2: Rate ratio, 0.52; 95% CI, 0.36-0.73; P <.001; AER depemokimab vs placebo: SWIFT-1 0.46 vs 1.11 and SWIFT-2 0.56 vs 1.08 exacerbations per year).1

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 trials showed a 72% reduction in the annualized rate of clinically significant exacerbations requiring hospitalisation and/or ED visits over 52 weeks for depemokimab compared with placebo (rate ratio, 0.28; 95% CI, 0.13-0.61; nominal P = .002; AER depemokimab 0.02 vs placebo 0.09).1

Across these trials, depemokimab was well-tolerated, with patients experiencing a similar rate and severity of side effects as those receiving placebo.1

“The struggle for people living with severe asthma is immense, with many silently enduring continued symptom recurrence and exacerbations. An innovative treatment option like Exdensur that offers the long-acting protection from exacerbations that severe asthma patients with an eosinophilic phenotype deserve, with the benefit of fewer doses, is truly welcome,” Tonya Winders, President and CEO, Global Allergy & Airways Patient Platform, said.1

References

1. GSK. Exdensur (depemokimab) approved by US FDA for the treatment of severe asthma. December 16, 2025. Accessed December 16, 2025. https://www.gsk.com/en-gb/media/press-releases/exdensur-depemokimab-approved-by-us-fda-for-the-treatment-of-severe-asthma/

2. Smith T. Positive Phase 3 Findings Identified for Depemokimab Treatment of Severe Asthma. September 9, 2024. Accessed December 16, 2025. https://www.hcplive.com/view/positive-phase-3-findings-identified-depemokimab-treatment-severe-asthma