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 (fluticasone furoate/vilanterol, FF/VI)” gsk.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT01376245 | Apr 2011 → Sep 2012 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | Met primary |
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 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 ↗
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. |
| 2017-02-23 | GlaxoSmithKline | Results Positive results for Relvar® Ellipta® lung function study in patients with well-controlled asthma gsk.com ↗
Issued: London UK – LSE Announcement GlaxoSmithKline plc (LSE/NYSE:GSK) and Innoviva, Inc. (NASDAQ: INVA) today announced positive headline results from a non-inferiority lung function study, which demonstrated that patients with well-controlled asthma were able to switch to the once-daily Relvar® Ellipta®(fluticasone furoate/vilanterol, FF/VI) 100/25 |
| 2014-09-08 | GlaxoSmithKline | Results GSK data presented at ERS demonstrate potential of blood eosinophil levels to help inform COPD treatment decisions gsk.com ↗ |
| 2014-07-04 | GlaxoSmithKline | Regulatory Anoro® Ellipta® (umeclidinium/vilanterol) gains approval in Japan for the treatment of COPD gsk.com ↗
“We are very pleased with this latest regulatory approval for Anoro Ellipta,” said Rick E Winningham, Chief Executive Officer of Theravance. |
| 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 ↗ |
| 2013-04-26 | GlaxoSmithKline | Regulatory GSK announces regulatory submission for umeclidinium monotherapy in European Union gsk.com ↗
A Marketing Authorisation Application (MAA) for UMEC monotherapy (55 mcg delivered dose) has been submitted to the European Medicines Agency (EMA), for a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD. |
| 2013-04-22 | GlaxoSmithKline | Regulatory GSK and Theravance announce regulatory submission for ANORO™ ELLIPTA™ (UMEC/VI) in Japan gsk.com ↗ |
| 2013-02-19 | GlaxoSmithKline | Regulatory GSK and Theravance announce FDA acceptance of New Drug Application (NDA) submission in the US for ANORO ELLIPTATM for COPD gsk.com ↗ |
| 2013-01-09 | GlaxoSmithKline | Regulatory GSK and Theravance announce regulatory submission for ANORO™ (UMEC/VI) in Europe gsk.com ↗
GlaxoSmithKline plc (LSE:GSK) and Theravance, Inc. (NASDAQ: THRX) today announced the submission of a regulatory application in the European Union for the investigational once-daily LAMA/LABA combination medicine, UMEC/VI, for patients with chronic obstructive pulmonary disease (COPD). |
| 2012-12-18 | GlaxoSmithKline | Regulatory GSK and Theravance announce regulatory submission for UMEC/VI (LAMA/LABA) in the US gsk.com ↗
A New Drug Application (NDA) for UMEC/VI (62.5/25mcg and 125/25mcg doses) with the proposed proprietary name ANORO ELLIPTA™ has been submitted to the US Food and Drug Administration (FDA), for the long-term once-daily maintenance bronchodilator treatment of airflow obstruction in patients with COPD, including chronic bronchitis and emphysema. |
All press releases naming this drug 15 releases
Evidence & citations 1 cited value
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 NCT01376245 ↗ |