GSK’s Exdensur Secures Japanese Approval

GSK plc (LSE/NYSE: GSK) announced a regulatory victory with Japan's Ministry of Health, Labour and Welfare (MHLW) approving Exdensur (depemokimab) for severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP).

This approval positions Exdensur as the first and only ultra-long-acting biologic in Japan for these conditions, potentially setting a new standard of care.

The MHLW's decision was underpinned by compelling data from the SWIFT and ANCHOR phase III trials. These trials demonstrated the sustained efficacy of Exdensur, administered in just two doses per year, compared to placebo when added to standard of care.

The SWIFT trials showcased substantial reductions in asthma exacerbations, while the ANCHOR trials revealed significant improvements in nasal polyp size and nasal obstruction, key indicators of CRSwNP severity.

Kaivan Khavandi, SVP and Global Head, Respiratory, Immunology & Inflammation R&D at GSK, highlighted the potential impact of this approval. He believes Exdensur could redefine treatment paradigms for severe asthma and CRSwNP patients in Japan, offering an ultra-long-acting option that suppresses type 2 inflammation with twice-yearly dosing.

The approval addresses a critical unmet need in Japan, where patients with severe asthma often experience frequent exacerbations, hospitalizations, and disease progression.

Similarly, individuals with CRSwNP face debilitating daily symptoms, with a significant proportion remaining uncontrolled despite standard treatments. Exdensur's extended half-life and sustained suppression of type 2 inflammation offer the promise of improved patient outcomes and reduced healthcare system burden.

Data from the SWIFT trials revealed impressive results, with depemokimab treatment leading to a 58% and 48% reduction in the rate of annualised asthma exacerbations over 52 weeks in SWIFT-1 and SWIFT-2, respectively. The ANCHOR trials also demonstrated clinically meaningful improvements, showing a reduction from baseline in nasal polyp score and nasal obstruction.