LONDON (dpa-AFX) - GSK plc (GSK) on Friday said China's National Medical Products Administration (NMPA) has approved Trelegy Ellipta for a new indication, allowing its use in adults aged 18 years and older with asthma. The approval expands the drug's existing authorization in China for the treatment of chronic obstructive pulmonary disease (COPD).
With the decision, Trelegy Ellipta-a combination of three active ingredients, fluticasone furoate, umeclidinium and vilanterol (FF/UMEC/VI)-becomes the first and only single-inhaler triple therapy approved in China for the long-term treatment of both asthma and COPD.
The approval was supported by results from GSK's CAPTAIN study, which showed that in patients whose asthma was not adequately controlled on inhaled corticosteroids combined with long-acting beta agonists (ICS/LABA), treatment with FF/UMEC/VI led to significantly greater improvements in lung function compared with FF/VI.
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