Exdensur (depemokimab) approved by US FDA for the treatment of severe asthma

GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Exdensur (depemokimab-ulaa) as an add-on maintenance treatment of severe asthma characterised by an eosinophilic phenotype in adult and pediatric patients aged 12 years and older.

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. Treatment with depemokimab resulted in a significant 58% and 48% reduction in the rate of annualized asthma exacerbations (asthma attacks) over 52 weeks from SWIFT-1 and SWIFT-2, respectively [rate ratio (95% confidence interval) p-value: SWIFT-1 0.42 (0.30, 0.59) p<0.001 and SWIFT-2 0.52 (0.36, 0.73) p<0.001] (AER depemokimab versus 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 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 [rate ratio 0.28, 95% CI (0.13, 0.61), nominal p=0.002] (AER depemokimab 0.02 versus placebo 0.09). Across these trials, depemokimab was well-tolerated, with patients experiencing a similar rate and severity of side effects as those receiving placebo.¹

Kaivan Khavandi, SVP & Global Head, Respiratory, Immunology & Inflammation R&D, GSK said: “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. Exdensur could redefine patient care and further establish the use of biologics for those who continue to experience exacerbations despite treatment.”

Depemokimab is a novel therapy that has been developed with an extended half-life, enabling the sustained suppression of disease-driving type 2 inflammation with twice-yearly dosing.¹ These distinct properties could potentially improve patient outcomes while reducing health system burden.

An estimated 2 million Americans live with severe asthma and half continue to experience frequent exacerbations that may lead to hospitalizations, emergency department visits and corresponding increased health system costs.^2,3,4 While biologics have demonstrated benefit in controlling severe asthma, only 20% of eligible patients in the US currently receive one, increasing their risk of exacerbations and worsening disease.⁵ Longer dosing intervals have been associated with an increased likelihood that patients would consider a biologic and 73% of physicians believe it would be beneficial.^6,7