The European Commission’s decision covers the treatment’s use in severe asthma and chronic rhinosinusitis.
The European Commission has approved GSK’s Exdensur (depemokimab) for both severe asthma and chronic rhinosinusitis with nasal polyps.
In severe asthma the biologic is indicated as an add-on maintenance treatment for type 2 inflammation, characterised by blood eosinophil count, in patients 12 years old and over who are inadequately controlled despite high dose inhaled corticosteroids plus another asthma controller.
The approval also covers Exdensur’s use as an add-on therapy alongside intranasal corticosteroids for adults with severe chronic rhinosinusitis with nasal polyps where systemic corticosteroids and/or surgery have not successfully controlled their disease.
Exdensur is the first EU-approved ultra-long-acting biologic for respiratory diseases that has already been approved in the US for severe asthma and in the UK and Japan for severe asthma and chronic rhinosinusitis with nasal polyps.
The product’s new European approvals are based on data from four phase III trials: SWIFT and ANCHOR. Data showed sustained efficacy with a twice-yearly dosing for Exdensur.
For instance, data from the SWIFT phase III trials showed the biologic reduced the annualised asthma exacerbations rate by 58 percent and 48 percent over 52 weeks in SWIFT-1 and SWIFT-2, respectively.
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 six months to protect patients from severe asthma exacerbations and the debilitating symptoms associated with chronic rhinosinusitis with nasal polyps.”
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"
Dr Stephanie Korn, PhD, Head of the Clinical Research Centre IKF Pneumologie Mainz, said: “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.”
Full findings from the ANCHOR trials were presented last year at the American Academy of Allergy, Asthma and Immunology (AAAAI) and World Allergy Organization (WAO) Joint Congress and published in The Lancet.
The SWIFT study results were presented at the 2024 European Respiratory Society International Conference and published in the New England Journal of Medicine.
GSK has made two developments in its respiratory pipeline in recent months, including its acquisition of Rapt Therapeutics for $2.2 billion in January.
Additionally, in October the pharmaceutical company released promising data supporting use of salbutamol MDI formulation as a next-generation low carbon propellant in respiratory diseases.
