China approves GSK's Exdensur for treating chronic rhinosinusitis
GSK PLC on Wednesday said its Exdensur drug, has been approved in China as an add-on therapy for the treatment of chronic rhinosinusitis with nasal polyps.
The approval of depemokinab, of which Exdensur is the brand name, for chronic rhinosinusitis in addition to intranasal corticosteroids by China’s National Medical Products Administration follows an earlier approval of the drug as an add-on treatment for severe asthma in patients over 12 by the same regulator.
GSK said the drug is the only ultra-long-acting biologic in China for the treatment of chronic rhinosinusitis with nasal polyps, which are growths in the nose or sinuses caused by inflammation. Half of the patients with the conditions are unable to get it under control, and up to 85% have underlying type 2 inflammation associated with more severe disease.
It is the sixth regulatory approval for the anti-asthma drug developed by the London-based pharmaceutical firm, which has also been authorised for marketing in the EU, the US, and Japan for either asthma or chronic rhinosinusitis conditions.
GSK shares were up 1.3% to 2,124.00 pence each on Wednesday morning in London.
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