Exdensur approved for the treatment of severe asthma in China

GSK has recently announced that China’s National Medical Products Administration has approved Exdensur as add-on maintenance treatment of severe asthma characterised by an eosinophilic phenotype in adult and paediatric patients aged 12 years and older.

Note that the approval 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.

Kaivan Khavandi, SVP, Global Head, Respiratory, Immunology & Inflammation R&D, GSK, said: “Today’s approval for Exdensur in China represents an important advance for patients with severe asthma with an eosinophilic phenotype. By providing sustained suppression of type 2 inflammation, an underlying driver of exacerbations and disease progression, Exdensur could redefine care in just two doses a year. With Exdensur now approved in several major markets, we are focused on transforming the treatment paradigm in severe asthma.”

In addition to secondary endpoints from SWIFT-1 and SWIFT-2, patients treated with depemokimab experienced numerically fewer exacerbations requiring hospitalisation and/or emergency department visits compared with placebo, 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.

Note that The NMPA is also reviewing Exdensur as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe chronic rhinosinusitis with nasal polyps for whom therapy with systemic corticosteroids and/or surgery does not provide adequate disease control.

---

---

Related Topics and Keywords

exdensur, GSK, severe asthma