The European Commission has granted marketing authorization for GSK's Exdensur (depemokimab), a novel biannual injection designed to treat patients with severe asthma characterized by type 2 inflammation. The approval expands the drug's labeled indication to also include chronic rhinosinusitis with nasal polyps (CRSwNP), a condition frequently occurring alongside severe asthma in certain patient populations.
The regulatory decision rests on efficacy data from phase 3 clinical trials demonstrating substantial reductions in disease exacerbations. Study results showed a 58% reduction in annualized asthma exacerbations and a 48% reduction in asthma exacerbations among patients with concurrent CRSwNP. The twice-yearly dosing regimen offers a potential advantage over more frequent injection schedules, potentially improving patient compliance and quality of life.
Market reaction to the approval was positive, with GSK shares advancing 2.65% to $60.49 in premarket trading. The authorization represents a significant commercial milestone for the company's respiratory portfolio and adds to the growing class of biologic therapies targeting type 2 inflammatory asthma phenotypes. Depemokimab targets IL-4 receptor alpha, a mechanism distinct from existing type 2 asthma therapeutics.