The SWIFT-1 and -2 phase 3 trials demonstrated "significantly" lower rate of annualized asthma exacerbations in patients receiving twice-yearly depemokimab vs placebo.
On December 16, 2025, the FDA approved depemokimab-ulaa (Exdensur; GSK) as an add-on
With the decision, depemokimab-ulaa is the first and only "ultra-long-acting biologic with twice-yearly dosing approved for patients with severe asthma with an eosinophilic phenotype," stated GSK, with approval based on the phase 3 SWIFT clinical trial program.
According to data from the SWIFT-1 and SWIFT-2 phase 3 trials, depemokimab-ulaa demonstrated a sustained exacerbation reduction with 2 doses per year compared to placebo, both plus standard of care. Specifically, treatment led to a 58% and 48% reduction in asthma attacks across 52 weeks in the SWIFT-1 and SWIFT-2 trials, respectively (rate ratio [95% CI] SWIFT-1: 0.42 [0.30, 0.59] P < 0.001; SWIFT-2: 0.52 [0.36, 0.73] P < 0.001).
SWIFT-1 and SWIFT-2 assessed the efficacy and safety of depemokimab adjunctive therapy in 382 and 380 participants with severe asthma who were randomised to receive depemokimab or a placebo, respectively. These patients received depemokimab in addition to standard of care treatment with a "medium to high-dose inhaled corticosteroids plus at least one additional controller," according to GSK. Full analysis of SWIFT-1 featured 250 patients in the treatment plus standard of care arm and 132 patients in the placebo plus standard of care arm. In SWIFT-2, 252 patients were included in the depemokimab plus SOC arm and 128 in the placebo plus SOC arm.2
A secondary endpoint was fewer exacerbations that required hospitalization and/or emergency department visits. Those treated with depemokimab in each trial experienced numerically fewer exacerbations that led to hospitalization/ED visits (1% and 4% vs 8% and 10%, respectively). Additionally, a 72% reduction in the annualized rate of clinically significant exacerbations that required hospitalization/ED visits was observed in a pre-specified pooled analysis of the trials with depemokimab vs placebo [rate ratio 0.28, 95% CI (0.13, 0.61), nominal P = 0.002] (AER depemokimab 0.02 versus placebo 0.09).1
“Current biologic treatments for asthma are often underutilised and frequent injections can be inconvenient for many patients and lead to inconsistent use," said Geoffrey Chupp, MD, Professor of Medicine, Pulmonary, Critical Care and Sleep Medicine, Yale University, in a statement. "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. [Depemokimab] could empower physicians and patients to potentially achieve their treatment goals with fewer injections.”
According to GSK, there are an estimated 2 million people in the United States living with severe asthma, with up to 50% who continue to experience exacerbations and hospitalizations.
"The struggle for people living with severe asthma is immense, with many silently enduring continued symptom recurrence and exacerbations," said Tonya Winders, President and CEO, Global Allergy & Airways Patient Platform in a statement. "An innovative treatment option like [depemokimab] 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.”
"Physicians in the US now have the option to provide sustained protection from exacerbations for patients living with severe asthma with an eosinophilic phenotype in just two doses a year," added GSK's SVP & Global Head, Kaivan Khavandi. "[Depokimab] could redefine patient care and further establish the use of biologics for those who continue to experience exacerbations despite treatment.”
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