Europe Clears GSK’s New Twice-Yearly Asthma Treatment

Vandana Singh

Fri, February 20, 2026 at 1:31 AM GMT+9 3 min read

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The European Commission on Tuesday approved **GSK plc’s **(NYSE:GSK) Exdensur (depemokimab) in two indications, including:

As an add-on maintenance treatment for severe asthma with type 2 inflammation, characterized by blood eosinophil count in adults and adolescents 12 years and older who are inadequately controlled despite high-dose inhaled corticosteroids plus another asthma controller.

As an add-on therapy with intranasal corticosteroids for adult patients with severe CRSwNP for whom therapy with systemic corticosteroids and/or surgery does not provide adequate disease control.

The approval is based on data from the SWIFT and ANCHOR phase 3 trials, which showed sustained efficacy with a twice-yearly dosing regimen for depemokimab.

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Trial Data

Each of the four trials met their primary or co-primary endpoints with statistically significant and clinically meaningful results, comparing the addition of depemokimab to standard of care versus standard of care alone.

Asthma affects more than 42 million people in Europe. About 5-10% of patients experience severe asthma, with many continuing to experience exacerbations and reduced quality of life despite treatment.

In addition, patients with CRSwNP face debilitating daily symptoms, and almost half remain uncontrolled.

Exdensur is a novel therapy that combines high interleukin-5 (IL-5) binding affinity and high potency with an extended half-life, enabling the sustained suppression of disease-driving type 2 inflammation with twice-yearly dosing.

In the SWIFT phase 3 trials, 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.

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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 hospitalisation and/or ED visits over 52 weeks for depemokimab compared with placebo.

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Additionally, in the ANCHOR phase 3 trials, treatment with depemokimab resulted in an improvement (reduction) from baseline in nasal polyp score (scale: 0-8) at 52 weeks and in the nasal obstruction verbal response scale over weeks 49-52.

Background

In December 2025, the U.S. Food and Drug Administration (FDA) approved Exdensur as an add-on maintenance treatment of severe asthma characterized by an eosinophilic phenotype in patients aged 12 years and older.

Also, Exdensur recently received approval in the U.K. and Japan for the treatment of severe asthma and CRSwNP.

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This article Europe Clears GSK’s New Twice-Yearly Asthma Treatment originally appeared on Benzinga.com

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