Drugs / fluticasone furoate/vilanterol
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | EU (EMA) | Relvar Ellipta | asthma | 2017-07-21 | “today announced a submission to the European Medicines Agency (EMA) for the extended use of once-daily Relvar Ellipta” gsk.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT01627327 | Apr → Dec 2012 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | Missed primary |
News releases announcing trial results or a regulatory action · 17
| Date | Issuer | Release |
|---|---|---|
| 2018-03-08 | GlaxoSmithKline | Regulatory GSK announces positive EU approval for labelling update to Relvar Ellipta in patients with asthma gsk.com ↗
We welcome this approval, which signifies an important milestone for Relvar Ellipta. |
| 2017-12-21 | GlaxoSmithKline | Regulatory FDA approves US label update on ICS/LABA combinations in asthma, based on review of safety data gsk.com ↗
The FDA also approved updates to the Warnings and Precautions section of labelling for the ICS/LABA class. |
| 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 ↗ |
| 2017-07-21 | GlaxoSmithKline | Regulatory GSK submits EU filing for extended use of Relvar Ellipta in patients with controlled asthma on an ICS/LABA combination gsk.com ↗ |
| 2017-02-23 | GlaxoSmithKline | Results Positive results for Relvar® Ellipta® lung function study in patients with well-controlled asthma gsk.com ↗
In this positive study we have demonstrated non-inferiority for once-daily Relvar versus twice-daily Seretide on lung function. |
| 2016-05-18 | GlaxoSmithKline | Results GSK presents new data from Breo® Ellipta® SUMMIT study in patients with COPD at ATS Conference gsk.com ↗
One demonstrated that patients with Chronic Obstructive Pulmonary Disease (COPD) and moderate airflow limitation receiving Breo® Ellipta® (fluticasone furoate/vilanterol or FF/VI 100/25mcg) achieved improvements in exacerbations compared with placebo. |
| 2015-04-30 | GlaxoSmithKline | Regulatory FDA approves BREO® ELLIPTA® for the treatment of adults with asthma in the US gsk.com ↗
Two strengths, 100/25mcg and 200/25mcg, have been approved in the US for use in asthma, administered once-daily using the Ellipta dry powder inhaler. |
| 2015-03-19 | GlaxoSmithKline | Regulatory GSK and Theravance announce outcome of US FDA Advisory Committee on BREO® ELLIPTA® in asthma gsk.com ↗
The FDA Advisory Committee voted that the efficacy and safety data for FF/VI 100/25 mcg and 200/25 mcg once daily in asthma support approval in adults 18 years of age and older (16 for, 4 against). |
| 2014-09-08 | GlaxoSmithKline | Results GSK data presented at ERS demonstrate potential of blood eosinophil levels to help inform COPD treatment decisions gsk.com ↗ |
| 2014-06-30 | GlaxoSmithKline | Regulatory GSK and Theravance announce submission to US regulatory authorities for fluticasone furoate/vilanterol in asthma gsk.com ↗ |
| 2014-06-11 | GlaxoSmithKline | Results GSK and Theravance announce positive data from two studies evaluating the efficacy and safety of Incruse™ Ellipta® when added to Relvar®/Breo® Ellipta® in patients with COPD gsk.com ↗
“We are pleased with the positive data from these two studies evaluating an open triple therapy, Incruse added to Relvar/Breo Ellipta,” said Rick E Winningham, Chief Executive Officer, Theravance. |
| 2013-12-06 | GlaxoSmithKline | Results GSK and Theravance announce positive results from pivotal phase III study for fluticasone furoate/vilanterol in asthma gsk.com ↗
GlaxoSmithKline (GSK) and Theravance, Inc. (NASDAQ: THRX) today announced positive results from a phase III efficacy and safety study of fluticasone furoate “FF”/vilanterol “VI” designed to support a potential filing for an asthma indication for adults in the US. |
| 2013-11-18 | GlaxoSmithKline | Regulatory RELVAR® ELLIPTA® receives European marketing authorisation for the treatment of asthma and COPD gsk.com ↗ |
| 2013-09-20 | GlaxoSmithKline | Regulatory RELVAR™ ELLIPTA™ gains approval in Japan for the treatment of asthma gsk.com ↗
today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved RELVAR™ ELLIPTA™ for the treatment of bronchial asthma (in cases where concurrent use of inhaled corticosteroid and long-acting inhaled beta2 agonist is required). |
| 2013-09-19 | GlaxoSmithKline | Regulatory RELVAR™ ELLIPTA™ receives positive opinion from the CHMP in Europe for the treatment of asthma and COPD gsk.com ↗ |
| 2013-05-10 | GlaxoSmithKline | Regulatory BREO™ ELLIPTA™ gains US approval for the treatment of COPD gsk.com ↗
GlaxoSmithKline plc (LSE/NYSE: GSK) and Theravance, Inc. (NASDAQ: THRX) today announced that the US Food and Drug Administration (FDA) has approved BREO™ ELLIPTA™ as an inhaled long-term, once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. |
| 2010-09-21 | GlaxoSmithKline | Results GSK and Theravance announce combination ICS/LABA Phase II results in the Relovair™ development programme gsk.com ↗
The most common adverse events (FFVI; placebo) were nasopharyngitis (18%;15%), headache (15%; 5%), dizziness (5%; 5%) and candidiasis (8%;0%). |
All press releases naming this drug 19 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | fluticasone furoate/vilanterol | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01627327 ↗ |
| Known as | FF/VI | “Fluticasone Furoate /Vilanterol (FF/VI) Inhalation Powder 100/25mcg” NCT01627327 ↗ |
| Route | Inhaled | “inhalation powder” NCT01627327 ↗ |