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# GSK, Innoviva sNDA for Trelegy Ellipta in Asthma
- URL: https://www.fdaweb.com/gsk-innoviva-snda-for-trelegy-ellipta-in-asthma/
- Published: 2019-10-02T12:00:00.000Z
- Updated: 2026-09-15T01:53:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145150

GlaxoSmithKline and Innoviva have submitted a supplemental NDA seeking an additional indication for once-daily use of Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) for treating asthma in adults. Trelegy Ellipta was originally approved 9/2017 for treating patients with chronic obstructive pulmonary disease (COPD). The submission is based on data from the pivotal Phase 3 clinical study (CAPTAIN) conducted in 2,436 adult patients with uncontrolled asthma across 15 countries. The CAPTAIN study demonstrated that the once-daily single inhaler triple therapy met the study’s primary endpoint of significant improvement in lung function compared with fluticasone furoate and vilanterol in patients with uncontrolled asthma, the companies said.