GSK plc announced that China's National Medical Products Administration (NMPA) has approved Exdensur (depemokimab) as add-on maintenance treatment of severe asthma characterised by an eosinophilic phenotype in adult and paediatric patients aged 12 years and older. The approval of Exdensur in severe asthma is based on data from the SWIFT-1 and SWIFT-2 phase III trials. In these studies, depemokimab demonstrated sustained exacerbation reduction with two doses per year versus placebo, both plus standard of care.
Asthma is a major health burden in China affecting an estimated 46 million adults. Of those, approximately 6% experience severe asthma, which is associated with an increased risk of exacerbations requiring hospitalisation, and higher likelihood of potentially fatal asthma attacks.2-6 In China, around 15% of people with asthma have experienced an exacerbation requiring a hospital visit in the preceding 12 months. In the SWIFT-1 and SWIFT-2 trials, treatment with depemokimab resulted in a significant 58% and 48% reduction in the rate of annualised asthma exacerbations (asthma attacks) over 52 weeks, respectively [rate ratio (95% confidence interval) p-value: SWIFT-1 0.42 (0.30, 0.59) p<0.001 and SWIFT-2 0.52 (0.36, 0.73) p<0.001] (AER depemokimab versus placebo: SWIFT-1 0.46 vs.
1.11 and SWIFT-2 0.56 vs. 1.08 exacerbations per year). In addition, efficacy and safety results from Chinese patients participating in SWIFT-1 were consistent with the overall population analysis (n=58).
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 (1% and 4%) compared with placebo (8% and 10%), respectively. A pre-specified pooled analysis of the two trials showed there was a 72% reduction in the annualised rate of clinically significant exacerbations requiring hospitalisation and/or ED visits over 52 weeks for depemokimab compared with placebo [rate ratio 0.28, 95% CI (0.13, 0.61), nominal p=0.002] (AER depemokimab 0.02 versus placebo 0.09). Across these trials, depemokimab was well-tolerated, with patients experiencing a similar rate and severity of side effects as those receiving placebo.
The NMPA is also reviewingExdensuras an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP) for whom therapy with systemic corticosteroids and/or surgery does not provide adequate disease control. Exdensurhas been approved in the US for the treatment of severe asthma, as well as in Japan, the EU, and UK for the treatment of severe asthma and CRSwNP.
