LONDON (dpa-AFX) - GSK plc (GSK) on Tuesday said the European Commission has approved Exdensur for two indications, including add-on maintenance treatment for severe asthma with type 2 inflammation in patients aged 12 years and older, and as an add-on therapy with intranasal corticosteroids for adults with severe chronic rhinosinusitis with nasal polyps (CRSwNP).
GSK said Exdensur is the first and only ultra-long-acting biologic approved in the European Union to treat respiratory diseases.
The decision was based on data from the Phase III SWIFT and ANCHOR trials, which demonstrated sustained efficacy with a twice-yearly dosing regimen.
Exdensur recently received approval in the United States for severe asthma and has also been granted marketing authorisation in the United Kingdom and Japan for the treatment of severe asthma and CRSwNP.
On Friday, GSK shares closed at $58.93 on the NYSE, up 0.67%.
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