Drugs / Fluticasone Furoate/Umeclidinium/Vilanterol
Fluticasone Furoate/Umeclidinium/Vilanterol
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed chronic obstructive pulmonary disease 1 milestone | |||||
| Filed | Japan (PMDA) | Trelegy Ellipta | chronic obstructive pulmonary disease | 2018-05-29 | “a regulatory application for once-daily fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI 100/62.5/25 mcg) under the proposed brand name Trelegy Ellipta has been submitted” theravance.com ↗ |
| Rejected acute asthma 1 milestone | |||||
| Refused (EMA) | EU (EMA) | Trelegy Ellipta | acute asthma | — | “negative opinion not to recommend the marketing authorisation for the medicinal product Trelegy Ellipta (FF/UMEC/VI) be updated to include an indication for adult asthma.” gsk.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 4 | NCT06905483 | Apr → Dec 2025 | chronic obstructive pulmonary disease | Thammasat University | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 18
| Date | Issuer | Release |
|---|---|---|
| 2025-05-02 | GlaxoSmithKline | Results GSK continues to advance the future of respiratory medicine and patient care with new data at ATS gsk.com ↗
Exacerbation Reduction in Patients with Asthma Following Initiation of Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) in the United States |
| 2020-02-27 | GlaxoSmithKline | Regulatory GSK filing accepted by European Medicines Agency for Trelegy Ellipta use in adult patients with asthma gsk.com ↗
today announced the acceptance of a regulatory submission seeking an additional indication for the use of once-daily, single-inhaler triple therapy, Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol or FF/UMEC/VI) for the treatment of asthma in adults by the European Medicines Agency (EMA). |
| 2019-05-02 | GlaxoSmithKline | Results Phase III CAPTAIN study of Trelegy Ellipta in patients with asthma meets primary endpoint gsk.com ↗ |
| 2018-11-12 | Theravance Biopharma | Regulatory Theravance Biopharma Highlights Expanded COPD Indication for Trelegy Ellipta in Europe theravance.com ↗ |
| 2018-11-09 | GlaxoSmithKline | Regulatory Once-daily Trelegy Ellipta gains expanded COPD indication in Europe gsk.com ↗
We are pleased that the European Commission has approved the expanded use of Trelegy Ellipta as this will enable even more COPD patients to benefit from this important medicine. |
| 2018-09-24 | Theravance Biopharma | Regulatory Theravance Biopharma Highlights Positive CHMP Opinion Supporting Expanded COPD Indication for Trelegy Ellipta in Europe theravance.com ↗ |
| 2018-09-21 | GlaxoSmithKline | Regulatory Trelegy Ellipta receives positive CHMP opinion supporting expanded COPD indication in Europe gsk.com ↗
The CHMP’s recommendation is based on a type II variation supported by data from the IMPACT study which showed Trelegy Ellipta was superior to the inhaled corticosteroid (ICS)/LABA Relvar/Breo Ellipta (FF/VI) and LAMA/LABA Anoro Ellipta (UMEC/VI) in patients with moderate to severe COPD on multiple clinically important endpoints, including reducing exacerbations and improving lung function and health related quality of life. |
| 2018-05-29 | Theravance Biopharma | Regulatory Theravance Biopharma Highlights Submission of Regulatory Application in Japan for Once-Daily Single Inhaler Triple Therapy FF/UMEC/VI for Patients with COPD theravance.com ↗ |
| 2018-05-16 | GlaxoSmithKline | Results GSK’s industry-leading respiratory research and scientific innovation showcased at ATS conference gsk.com ↗
Reduction in All-Cause mortality with Single Inhaler Triple Therapy (FF/UMEC/VI) versus Dual Therapy (FF/VI and UMEC/VI) in Patients with COPD: Prespecified analysis of the Phase III IMPACT trial |
| 2018-04-18 | GlaxoSmithKline | Results Landmark IMPACT study published in NEJM shows significant benefits of Trelegy Ellipta for patients with COPD gsk.com ↗
A significant reduction in the risk of on-treatment all-cause mortality was observed for both inhaled corticosteroid containing arms compared to Anoro. |
| 2018-02-14 | GlaxoSmithKline | Regulatory GSK submits landmark IMPACT data to European Medicines Agency to support expanded label for Trelegy Ellipta gsk.com ↗ |
| 2017-11-23 | GlaxoSmithKline | Regulatory GSK submits landmark IMPACT data to US regulatory authority to support expanded label for Trelegy Ellipta gsk.com ↗
today announced the filing of a supplemental New Drug Application (sNDA) with the US Food and Drug Administration (FDA) |
| 2017-11-16 | GlaxoSmithKline | Regulatory Trelegy Ellipta once-daily single inhaler triple therapy gains marketing authorisation in Europe for the treatment of COPD gsk.com ↗
Issued: London GlaxoSmithKline plc (LSE/NYSE: GSK) and Innoviva, Inc. (NASDAQ: INVA) today announced that the European Commission has granted marketing authorisation for Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol, ‘FF/UMEC/VI’) as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist. |
| 2017-09-20 | GlaxoSmithKline | Results GSK and Innoviva report positive headline results from IMPACT study showing single inhaler triple therapy Trelegy Ellipta reduced COPD exacerbations gsk.com ↗
The IMPACT study, which involved 10,355 patients, met its primary endpoint demonstrating statistically significant reductions in the annual rate of on-treatment moderate/severe exacerbations for FF/UMEC/VI (100/62.5/25mcg) when compared with two, once-daily dual COPD therapies from GSK’s existing portfolio. |
| 2017-09-20 | Theravance Biopharma | Results Theravance Biopharma Highlights Positive Headline Results from IMPACT Study of Trelegy Ellipta Announced by GlaxoSmithKline and Innoviva theravance.com ↗
Theravance Biopharma, Inc. (NASDAQ: TBPH) (" Theravance Biopharma ") today highlighted that GlaxoSmithKline plc (GSK) and Innoviva, Inc. ( Innoviva ) have reported positive headline results from the landmark Phase 3 IMPACT study of Trelegy Ellipta |
| 2017-09-18 | GlaxoSmithKline | Regulatory Trelegy Ellipta approved as the first once-daily single inhaler triple therapy for the treatment of appropriate patients with COPD in the US gsk.com ↗
It is the first once-daily product approved in the US that combines three active molecules in a single inhaler for the maintenance treatment of appropriate patients with COPD. |
| 2016-12-02 | GlaxoSmithKline | Regulatory GSK files EU regulatory submission for once-daily closed triple combination therapy FF/UMEC/VI for patients with COPD gsk.com ↗ |
| 2016-11-21 | GlaxoSmithKline | Regulatory GSK files regulatory submission in US for once-daily closed triple combination therapy FF/UMEC/VI for patients with COPD gsk.com ↗
Issued: London GlaxoSmithKline plc (LSE/NYSE: GSK) and Innoviva, Inc. (NASDAQ: INVA) today announced the filing by GSK of a regulatory submission with the US Food and Drug Administration for the once-daily, closed triple combination therapy fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI 100/62.5/25 mcg) for patients with chronic obstructive pulmonary disease (COPD). |
All press releases naming this drug 23 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Fluticasone Furoate/Umeclidinium/Vilanterol | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06905483 ↗ |
| Known as | FF/UM/VI | “METHODS: Three-dimensional airway models were produced from 20 patients with moderate-to-very severe COPD. Total, central, and regional small airways deposition as a percentage...” PMID 37742015 ↗ Sep 2023 |
| Known as | FF/UMEC/VI | “BACKGROUND: Single-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62.5/25 μg has been shown to improve lung function and health status, and reduce...” PMID 29370819 ↗ Jan 2018 |
| Known as | FluF/VI/UMEC | “INTRODUCTION: There is a clear correlation between small airways dysfunction and poor clinical outcomes in patients with chronic obstructive pulmonary disease (COPD), and it is...” PMID 33116458 ↗ Oct 2020 |
| Route | Inhaled | “FUV (100/62.5/25 mcg) 1 inhalation, once daily for 4 weeks” NCT06905483 ↗ |