Drugs / Trelegy Ellipta
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed asthma 3 milestones | |||||
| Refused (EMA) | EU (EMA) | Trelegy Ellipta | 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 ↗ |
| Filed | Japan (PMDA) | Trelegy Ellipta | asthma | — | “Submissions for the use of Trelegy Ellipta for the treatment of adult asthma patients were accepted for filing in the US by the FDA in December 2019 and in Japan by the...” gsk.com ↗ |
| Filed | US (FDA) | Trelegy Ellipta | asthma | — | “Submissions for the use of Trelegy Ellipta for the treatment of adult asthma patients were accepted for filing in the US by the FDA in December 2019” gsk.com ↗ |
| Filed COPD, severe early onset 1 milestone | |||||
| Filed | US (FDA) | Trelegy Ellipta | COPD, severe early onset | 2017-11-23 | “today announced the filing of a supplemental New Drug Application (sNDA) with the US Food and Drug Administration (FDA) for the use of Trelegy Ellipta” gsk.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Approved | EU (EMA) | Trelegy Ellipta | — | 2017-11-15 | europa.eu ↗ |
| Approved | US (FDA) | TRELEGY ELLIPTA | — | 2017-09-18 | fda.gov ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 4 | NCT06282861 | Feb 2024 → Jan 2025 | chronic obstructive pulmonary disease | Fundacio Privada Mon Clinic Barcelona | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT04606394 | Dec 2020 → Dec 2021 | chronic obstructive pulmonary disease | Pulmonary Research Institute of Southeast Michigan | Completed | Missed primary |
News releases announcing trial results or a regulatory action · 16
| Date | Issuer | Release |
|---|---|---|
| 2026-01-23 | GlaxoSmithKline | Regulatory Trelegy Ellipta approved in China for use in adults with uncontrolled asthma gsk.com ↗
The approval means that FF/UMEC/VI is the first and only single inhaler triple therapy (SITT) approved for the maintenance treatment of both respiratory conditions in the country. |
| 2020-09-09 | GlaxoSmithKline | Regulatory FDA approves Trelegy Ellipta as the first once-daily single inhaler triple therapy for the treatment of both asthma and COPD in the US gsk.com ↗
The approval means 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. |
| 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) |
| 2019-10-02 | GlaxoSmithKline | Regulatory GSK submits filing to FDA for Trelegy Ellipta use in patients with asthma gsk.com ↗ |
| 2019-05-02 | GlaxoSmithKline | Results Phase III CAPTAIN study of Trelegy Ellipta in patients with asthma meets primary endpoint gsk.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. |
| 2018-09-21 | GlaxoSmithKline | Regulatory Trelegy Ellipta receives positive CHMP opinion supporting expanded COPD indication in Europe gsk.com ↗ |
| 2018-05-29 | GlaxoSmithKline | Regulatory GSK submits regulatory application in Japan for once-daily single inhaler triple therapy FF/UMEC/VI for patients with COPD gsk.com ↗
We are delighted to have filed a new drug application for the first single inhaler triple therapy for the treatment of COPD in Japan where the prevalence of COPD is of public concern. |
| 2018-04-24 | GlaxoSmithKline | Regulatory Once-daily Trelegy Ellipta gains expanded indication in the US for the treatment of patients with COPD gsk.com ↗
We are pleased that the robust data from the IMPACT study has enabled the expanded indication announced today and the FDA action has been taken so swiftly. |
| 2018-04-18 | GlaxoSmithKline | Results Landmark IMPACT study published in NEJM shows significant benefits of Trelegy Ellipta for patients with COPD gsk.com ↗
A 42.1% reduction in the risk of on-treatment all-cause mortality was observed for Trelegy compared to Anoro (1.20% vs. 1.88%; p=0.011). |
| 2018-02-14 | GlaxoSmithKline | Regulatory GSK submits landmark IMPACT data to European Medicines Agency to support expanded label for Trelegy Ellipta gsk.com ↗
GlaxoSmithKline plc (LSE/NYSE: GSK) and Innoviva, Inc. (NASDAQ: INVA) today announced the submission of the landmark IMPACT data to the European Medicines Agency |
| 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) for the use of Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol, ‘FF/UMEC/VI’) for an expanded indication for the maintenance treatment of airflow obstruction and reduction of exacerbations in patients with chronic obstructive pulmonary disease (COPD). |
| 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 ↗
Trelegy Ellipta is the first once-daily single inhaler triple therapy to be approved in Europe. |
| 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 ↗ |
| 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. |
| 2017-09-15 | GlaxoSmithKline | Regulatory Trelegy Ellipta once-daily single inhaler triple therapy receives positive opinion from the CHMP in Europe for appropriate patients with COPD gsk.com ↗ |
All press releases naming this drug 16 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Trelegy Ellipta | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04606394 ↗ |
| Route | Inhaled | “Trelegy Ellipta 100/62.5/25Mcg Inh 30D” NCT04606394 ↗ |