GSK has secured European Commission approval for Exdensur (depemokimab) to treat severe asthma with type 2 inflammation and chronic rhinosinusitis with nasal polyps, marking the arrival of the first ultra‑long‑acting biologic for respiratory conditions in the EU.
The decision covers two indications: add‑on maintenance treatment for adults and adolescents aged 12 and over with severe asthma with type 2 inflammation who remain inadequately controlled despite high dose inhaled corticosteroids plus another asthma controller, and add‑on therapy for adults with severe chronic rhinosinusitis with nasal polyps whose symptoms are not adequately managed with systemic corticosteroids or surgery.
Approval was based on data from the SWIFT and ANCHOR phase 3 trials, which demonstrated sustained efficacy with twice‑yearly dosing. All four trials met their primary or co‑primary endpoints with statistically significant and clinically meaningful results.
Kaivan Khavandi, SVP, Global Head, Respiratory, Immunology & Inflammation R&D at 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.”
Asthma affects more than 42 million people in Europe, with 5–10% experiencing severe disease. Patients with chronic rhinosinusitis with nasal polyps also face daily symptoms, and almost half remain uncontrolled. Exdensur combines high interleukin‑5 binding affinity and potency with an extended half‑life to deliver sustained suppression of type 2 inflammation.
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.”
Eugenio De Corso, MD, PhD, added: “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.”
