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GSK and Innoviva's Trelegy Ellipta (FF/UMEC/VI) Receive the US FDA's Approval for Asthma and COPD

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GSK and Innoviva's Trelegy Ellipta (FF/UMEC/VI) Receive the US FDA's Approval for Asthma and COPD

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  • The approval is based on an sNDA which includes data from CAPTAIN study assessing Trelegy (qd- 100/62.5/25- 200/62.5/25- 100/31.25/25- and 200/31.25/25 mcg) vs FF/VI (100/25 and 200/25 mcg) to patients whose asthma was inadequately controlled despite treatment with ICS/LABA
  • Results: Trelegy (qd- easy-to-use inhaler) demonstrated improvements in lung function- presented at ERS Congress. The FDA-approved strength for both COPD and asthma is FF/UMEC/VI (100/62.5/25mcg) and additional strength for asthma alone is FF/UMEC/VI (200/62.5/25mcg)
  • Trelegy is the first single inhaler triple therapy approved for the maintenance treatment of both asthma and COPD and is the only single inhaler triple therapy available for patients in a convenient once-daily inhalation in the US

­ Ref: GSK | Image: GSK 

Click here to­ read the full press release 

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