FDA Accepts Biologics License Application for GSK’s Depemokimab for Asthma with Type 2 Inflammation and CRSwNP

Image Credit: Adobe Stock Images/Matthieu

The FDA has accepted GSK’s Biologics License Application for depemokimab as an add-on maintenance treatment for asthma with type 2 inflammation and chronic rhinosinusitis with nasal polyps (CRSwNP). The submission was based on results from the Phase III SWIFT and ANCHOR trials, in which depemokimab demonstrated efficacy in reducing inflammation.^1,2

“Simultaneous regulatory submissions for two indications highlight our confidence in depemokimab to help reduce the burden of both asthma and CRSwNP for patients and health systems. Our SWIFT and ANCHOR trials support depemokimab’s potential to suppress interleukin-5 (IL-5), a known driver of type 2 inflammation, to offer patients sustained inhibition of a key driver of their disease with just two doses per year,” said Kaivan Khavandi, SVP, global head, respiratory, immunology & inflammation R&D, GSK, in a press release.

The global, 52-week, randomized, double-blind, parallel-group, placebo-controlled, multicenter ANCHOR-1 and ANCHOR-2 trials evaluated the safety and efficacy of depemokimab in patients with CRSwNP. In ANCHOR-1, 143 patients were treated with depemokimab plus standard-of-care (SOC), and 128 were treated with placebo. In ANCHOR-2, there were 129 patients in the depemokimab plus SOC group and 128 in the placebo group. The dual primary endpoints were meaningful and statistically significant improvements in nasal polyp size and nasal obstruction.²

The 52-week, randomized, double-blind, placebo-controlled, parallel-group, multicenter SWIFT-1 and SWIFT-2 trials evaluated the efficacy and safety of depemokimab in patients with severe asthma with type 2 inflammation characterized by blood eosinophil count. Patients were randomly assigned in a 2:1 ratio to receive depemokimab or placebo, along with SOC. SWIFT-1 included 250 patients in the depemokimab arm and 132 in the placebo arm. In SWIFT-2, there were 252 patients in the depemokimab arm and 128 patients in the placebo arm.¹

Results from the ANCHOR trials demonstrated that depemokimab showed statistically significant reductions in nasal polyp size and obstruction versus placebo. Additional analyses demonstrated improvements in rhinorrhea, loss of smell, sinus imaging scores, and quality-of-life measures.

Further, 74% of patients administered depemokimab avoided systemic corticosteroids, surgery, or disease-modulating medication at 52 weeks, compared to 64% on placebo. Rates of adverse events (AEs) were similar in both treatment arms. No serious AEs were considered to be treatment-related and less than 1% of patients treated with depemokimab withdrew from the study due to AEs.²

Results from the SWIFT trials, which were published in the New England Journal of Medicine, found that the annualized rate of exacerbations in SWIFT-1 was 0.46 (95% confidence interval [CI]), 0.36 to 0.58) in the depemokimab cohort compared to 1.11 (95% CI, 0.86 to 1.43) in the placebo cohort (rate ratio, 0.42; 95% CI, 0.30 to 0.59; P<0.001). In the SWIFT-2 trial, the annualized rate of exacerbations was 0.56 (95% CI, 0.44 to 0.70) in the depemokimab cohort compared to 1.08 (95% CI, 0.83 to 1.41) in the placebo cohort (rate ratio, 0.52; 95% CI, 0.36 to 0.73; P<0.001).³

According to GSK, approximately 26 million people in the United States are currently living with asthma. Additionally, 40% have reported at least one asthma attack in the past year. In terms of chronic rhinosinusitis, it affects 2.1% of the US population, and 30% of those patients also have nasal polyps.¹

“Today’s data build on the body of evidence supporting depemokimab as an ultra-long-acting treatment and demonstrate significant reductions in nasal polyps with a twice-yearly dosing regimen. With nearly 40% of patients needing repeat surgeries and many requiring long-term systemic corticosteroids, there is a clear medical need for alternative treatment options to provide sustained symptom improvement and help alleviate the debilitating burden of this disease,” said Khavandi in a press release.

The FDA set a Prescription Drug User Fee Act date of December 16, 2025. Currently, depemokimab is not approved by any global regulatory body.¹

References

1. Depemokimab applications accepted for review by the US FDA for asthma with type 2 inflammation and for chronic rhinosinusitis with nasal polyps (CRSwNP). GSK. March 3, 2025. Accessed March 3, 2025. https://www.gsk.com/en-gb/media/press-releases/depemokimab-applications-accepted-for-review-by-the-us-fda/

2. Depemokimab delivers clinically meaningful and statistically significant improvements for patients with chronic rhinosinusitis with nasal polyps (CRSwNP). GSK. March 1, 2025. Accessed March 3, 2025. https://www.gsk.com/en-gb/media/press-releases/depemokimab-delivers-clinically-meaningful-and-statistically-significant-improvements-for-patients-with-chronic-rhinosinusitis-with-nasal-polyps-crswnp/

3. Twice-Yearly Depemokimab in Severe Asthma with an Eosinophilic Phenotype. The New England Journal of Medicine. Accessed March 3, 2025. https://www.nejm.org/doi/full/10.1056/NEJMoa2406673