GSK’s triple-combo COPD drug Trelegy wins market nod in China

UK major GlaxoSmithKline PLC’s (NYSE: GSK) triple therapy Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) picked up market approval from China's National Medical Products Administration (NMPA) as a treatment for chronic obstructive pulmonary disease (COPD). The product was filed for marketing approval in China in June 2018 and granted priority review status in September.

Fluticasone furoate is a corticosteroid that exerts an anti-inflammatory effect, while umeclidinium is a long-acting muscarinic antagonist (LAMA), and vilanterol is a LABA which relaxes the muscles in the airways by targeting beta2-receptors. The results of the Phase III clinical study IMPACT show Trelegy can significantly reduce the annual incidence of acute exacerbations compared with Relvar (fluticasone furoate and vilanterol trifenatate) and Anoro (umeclidinium and vilanterol trifenatate), two conventional therapies.

Trelegy won a first global approval from the US FDA in September, 2017, as the world’s first triple therapy for COPD. The drug, which is inhaled by patients once per day, generated GBP 156 million in global sales in 2018. GSK now has a rich COPD product portfolio available in China, including Seretide (salmeterol xinafoate/fluticasone propionate), first approved in 2001, and Anoro (umeclidinium and vilanterol) and Relvar (fluticasone, vilanterol), both approved in 2018.


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