GSK's Exdensur gets green light from Chinese regulator

(Sharecast News) - Drugmaker GSK said on Wednesday that China's National Medical Products Administration has approved Exdensur as an add‑on therapy with intranasal corticosteroids for adults with chronic rhinosinusitis with nasal polyps who do not achieve adequate control with systemic steroids or surgery. GSK noted that the NMPA's decision follows its recent approval of Exdensur as an add‑on maintenance treatment for severe eosinophilic asthma in adults and adolescents aged 12 and over.

The FTSE 100-listed gruop said the regulator's approval was supported by data from its recent phase III ANCHOR‑1 and ANCHOR‑2 trials, which showed reductions in nasal polyp score at 52 weeks and improvements in nasal obstruction scores over weeks 49-52. Across both studies, Exdensur was generally well‑tolerated, with side‑effect rates similar to placebo plus standard care.

GSK's Kaivan Khavandi said: "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."

As of 0930 BST, GSK shares were up 1.81% at 2,134p.

Reporting by Iain Gilbert at Sharecast.com

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