-- GSK's (GSK.L) Exdensur was approved in China as the first and only ultra-long-acting biologic for adult patients suffering from chronic rhinosinusitis with nasal polyps, according to a Wednesday filing.
The disease is caused by an inflammation of the nasal lining, which can lead to soft tissue growths or nasal polyps, causing nasal obstruction, loss of smell, facial pain, sleep disturbance, infections, and nasal discharge.
Authorization from the National Medical Products Administration stipulated the use of Exdensur, or depemokimab, as an add-on treatment with intranasal corticosteroids in people who do not experience "adequate" disease control from systemic corticosteroids and/or surgery.
The regulatory approval was based on the results of two phase 3 trials, Anchor-1 and Anchor-2, where Exdensur showed improvement in nasal polyp score and nasal obstruction verbal response scale from baseline. The drug was well-tolerated, with the rate and severity of side effects staying in line with placebo plus standard of care.
"Given the continued unmet need amongst patients with CRSwNP, today's approval of Exdensur could redefine care by protecting from the debilitating symptoms of this disease in just two doses a year. This builds on Exdensur's recent approval in severe asthma, which means more patients in China could have access to this first and only ultra-long-acting biologic," said Kaivan Khavandi, the head of translational and development sciences at GSK.
Besides China, Exdensur is already approved in Japan, the European Union, and the UK for severe asthma and chronic rhinosinusitis with nasal polyps and in the US for severe asthma.
GSK shares climbed over 1% in London during late morning trade.