The US FDA has approved GSK’s Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) for treating asthma. The drug is indicated for treating patients of 18 years and older. The drug is not indicated for acute bronchospasm.
The drug approval is based on the CAPTAIN study, a randomized, double-blind, active controlled, six-arm parallel group study. The drug is compared with Breo Ellipta (fluticasone furoate/ vilanterol), change from baseline in trough FEV1 at 24 weeks of treatment was considered as primary endpoint. Trelegy Ellipta demonstrated statistically significant 110ml improvement in FF/UMEC/VI 100/62.5/25mcg group compared with Relvar/Breo. An improvement of 92mL improvement in trough FEV1 was observed in FF/UMEC/VI 200/62.5/25mcg versus Relvar Ellipta. Moderate/severe exacerbations were considered as secondary enpoint.
The strength approved for treating COPD and asthma are fluticasone furoate / umeclidinium / vilanterol 100/62.5/25mcg. The other strength approved for asthma alone is fluticasone furoate / umeclidinium / vilanterol 200/62.5/25mcg.
The company has announced that Trelegy Ellipta is the first triple therapy approved in the United States for treating COPD and asthma.
The drug has been approved in the US and Europe for COPD in 2017. GSK has received the approval for treating asthma in the US on September 9, 2020.
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