GSK announces China’s NMPA approved Exdensur as add-on therapy

GSK (GSK) announced that China’s National Medical Products Administration, NMPA, has approved Exdensur as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with CRSwNP for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control. This follows the NMPA’s recent approval for Exdensur as an 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 CRSwNP is based on data from the ANCHOR-1 and ANCHOR-2 phase III trials, which showed an improvement from baseline in nasal polyp score at 52 weeks and in nasal obstruction verbal response scale over weeks 49-52. Across these trials, depemokimab was well-tolerated, with patients experiencing a similar rate and severity of side effects as those receiving placebo plus standard of care.