On February 17, 2026, GSK plc announced that the European Commission approves Exdensur – depemokimab in two indications –
- As an add-on maintenance treatment when it comes to critical asthma with type 2 inflammation that stands characterised by a blood eosinophil count within adults and also adolescents 12 years and above who happen to be inadequately controlled in spite of high dose inhaled corticosteroids – ICS plus another asthma controller.
- As an add-on therapy having intranasal corticosteroids when it comes to the treatment of adult patients having critical CRSwNP for whom the therapy with systemic corticosteroids and/or surgery does not offer the right disease control.
Interestingly, as European Commission approves Exdensur – depemokimab, it is indeed based upon data coming from the SWIFT and ANCHOR phase III trials, which have shown sustained efficacy with a dosing regimen of twice per year for depemokimab. Apparently, each of the four trials did go on to meet their primary or even co-primary endpoints, having statistically prominent and clinically meaningful outcomes, comparing the addition of depemokimab to the standard of care as against the standard of care alone.
The SVP and Global Head, Respiratory, Immunology & Inflammation R&D, GSK, Kaivan Khavandi, said, “The approval of Exdensur in the EU means there is now an innovative ultra-long-acting option that offers sustained efficacy over 6 months to protect patients from severe asthma exacerbations and the debilitating symptoms associated with CRSwNP. Exdensur may help redefine care for the millions of patients living with these persistent and burdensome conditions, supporting them in achieving their treatment goals with just two doses a year.”
It is well to be noted that asthma goes on to affect over 42 million people in Europe, with around 5-10% of patients experiencing severe asthma. Many of them continue to experience aggravation and also decreased quality of life in spite of the treatment.
Besides, patients having CRSwNP face debilitating everyday symptoms, and around half of them remain uncontrolled.
Exdensur happens to be a novel therapy that mixes high interleukin-5 – IL-5 binding affinity and also high potency, having an extended half-life, hence helping with sustained suppression when it comes to the disease-driving type 2 inflammation, having twice-yearly dosing, which could as well address continued unmet requirements in these diseases.
Head of the Clinical Research Centre IKF Pneumologie Mainz, Stephanie Korn, MD, PhD, said, “People living with the burden of severe asthma face persistent exacerbations driven by uncontrolled type 2 inflammation. A new option with twice-yearly dosing that could provide sustained suppression of type 2 inflammation is a promising innovation for patients in Europe with severe asthma who are in urgent need of novel solutions.”
Professor at the University of Perugia, Eugenio De Corso, MD, PhD, said, “CRSwNP profoundly impacts a patient’s daily life, causing debilitating nasal obstruction, which can make breathing, smelling, sleeping, and other fundamental activities a major challenge. An innovative treatment option like Exdensur, which could help patients achieve their treatment goals in fewer doses, represents an important advance.”
Notably, when it came to the SWIFT phase III trials of treatment with depemokimab, it resulted in a prominent 58% and 48% decrease in the rate of annualized asthma aggravations – asthma attacks in a period of 52 weeks in terms of SWIFT-1 and SWIFT-2, respectively, with the 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 against placebo- SWIFT-1 0.46 vs. 1.11 and SWIFT-2 0.56 vs.1.08 aggravations per year.
When it came to the secondary endpoint from SWIFT-1 and SWIFT-2, patients who were treated with depemokimab went on to experience numerically lesser aggravations needing hospitalization and/or emergency department visits, with just 1% and 4% as compared with the placebo at 8% and 10%, respectively.
A pre-specified pooled evaluation of both the trials showed there was a 72% decrease in the yearly rate of clinically prominent aggravations needing hospitalization and/or emergency department visits in a period of 52 weeks for depemokimab as compared to the placebo – rate ratio of 0.28, 95% CI (0.13, 0.61), nominal p=0.002 (AER depemokimab 0.02 as against placebo 0.09). The complete results from the SWIFT trials happened to be presented at the 2024 European Respiratory Society International Conference and were published in the New England Journal of Medicine.
Moreover, when it came to the ANCHOR phase III trials, depemokimab treatment resulted in an enhancement – reduction from the baseline in nasal polyp score – scale: 0-8 at 52 weeks with a treatment difference (95% confidence interval) p-value: ANCHOR-1 -0.7 (-1.1, -0.3) p<0.001 and ANCHOR-2 -0.6 (-1.0, -0.2) p=0.004] and in nasal obstruction verbal response scale (scale: 0-3) over weeks 49-52 [treatment difference (95% confidence interval) p-value: ANCHOR-1 -0.23 (-0.46, <0.00) p=0.047 and ANCHOR-2 -0.25 (-0.46, -0.03) p=0.025. The overall results from the ANCHOR trials were put forth at the 2025 American Academy of Allergy, Asthma and Immunology – AAAAI and World Allergy Organization – WAO Joint Congress and got published in The Lancet.
Throughout these trials, depemokimab was pretty well-tolerated, with patients going through a similar rate as well as side effect severity compared to those receiving placebo.
Apparently, Exdensur recently went on to receive approval in the US when it comes to the treatment of severe asthma, along with marketing authorization in the UK as well as Japan when it came to the treatment of severe asthma as well as CRSwNP.
SWIFT Phase III trials – An Introduction
It is worth noting that the SWIFT-1 and SWIFT-2 clinical trials evaluated the efficacy as well as safety of depemokimab adjunctive therapy in 382 and 380 participants having critical asthma who were randomized to get depemokimab or a placebo, respectively, besides their standard of care – SOC treatment with medium- to high-dose inhaled corticosteroids along with at least one more controller. The full evaluation set in SWIFT-1 went on to include 250 patients in the depemokimab plus SOC arm as well as 132 in the placebo plus SOC arm, whereas in SWIFT-2, 252 patients were included in the depemokimab plus SOC arm as well as 128 in the placebo plus SOC arm.
ANCHOR phase III trials – What is it about?
Notably, ANCHOR-1 went on to include 143 patients when it came to the depemokimab plus SOC arm and 128 within the placebo plus SOC arm, whereas in ANCHOR-2, 129 patients were included in the depemokimab plus SOC arm and 128 in the placebo plus SOC arm. Apparently, all the 528 patients had, in a way, inadequately controlled CRSwNP that had nasal polyps in both the nasal cavities with an endoscopic bilateral NPS ≥5 and had also either gone through previous surgery when it comes to CRSwNP, had gotten previous treatment with SCS, or were in fact intolerant to SCS. Patients went on to receive depemokimab or placebo at six-monthly intervals, or 26 weeks, besides SOC – maintenance intranasal corticosteroids.
About Exdensur – depemokimab
Exdensur happens to be the first ultra-long-acting biologic that is being assessed for certain respiratory diseases having underlying type 2 inflammation, like severe asthma as well as CRSwNP. It mixes high interleukin-5 -IL-5 binding affinity along with high potency, having an extended half-life to help with dosing twice every year. IL-5 is a major cytokine when it comes to type 2 inflammation.
Depemokimab development programme – An Introduction
Depemokimab is at present getting assessed in phase III trials when it comes to the treatment of other diseases having underlying type 2 inflammation, which includes OCEAN for eosinophilic granulomatosis with polyangiitis – EGPA as well as DESTINY for hypereosinophilic syndrome – HES.
GSK has also gone ahead and started the ENDURA-1, ENDURA-2, and VIGILANT phase III trials evaluating the efficacy as well as the safety of depemokimab of being an add-on therapy for patients having uncontrolled moderate to critical COPD having type 2 inflammation.
GSK in Respiratory
The fact is that GSK consistently builds on decades of landmark work that it has done in order to deliver more ambitious treatment objectives, come up with the next generation benchmark of care, and also redefine the respiratory medicine future when it comes to umpteen number of people having respiratory diseases.
Because of an industry-leading respiratory portfolio along with a pipeline of vaccines, inhaled medicines, and targeted biologics, GSK is indeed focused in terms of enhancing results as well as the lives of people who live with all kinds of asthma as well as COPD in addition to the less understood refractory chronic cough or even rarer conditions such as systemic sclerosis having interstitial lung disease. GSK is indeed making utmost use of the latest science and technology with the objective of modifying underlying disease dysfunction along with preventing any kind of progression.
