Exdensur now approved for severe asthma with type 2 inflammation and chronic rhinosinusitis with nasal polyps

GSK has recently announced that the European Commission has approved Exdensur in two indications:

• as add-on maintenance treatment for severe asthma with type 2 inflammation characterised 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 the treatment of adult patients with severe CRSwNP for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control.

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

Kaivan Khavandi, SVP, Global Head, Respiratory, Immunology & Inflammation R&D, GSK, 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.”

Stephanie Korn, MD, PhD, Head of the Clinical Research Centre IKF Pneumologie Mainz, 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.”

Eugenio De Corso, MD, PhD, Professor at University of Perugia, said: “CRSwNP profoundly impacts a patient’s daily life, causing debilitating nasal obstruction which can make breathing, smell, sleeping and other fundamental activities a major challenge. An innovative treatment option like Exdensur, that could help patients achieve their treatment goals in fewer doses, represents an important advance.”

In a secondary endpoint from SWIFT-1 and SWIFT-2, patients treated with depemokimab experienced numerically fewer exacerbations requiring hospitalisation and/or emergency department visits compared with placebo, respectively.

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Related Topics and Keywords

asthma, Chronic Rhinosinusitis, Exdensur (depemokimab), GSK, Nasal Polyps