Drugs / Umeclidinium/vilanterol
Umeclidinium/vilanterol
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | EU (EMA) | — | COPD, severe early onset | — | “Regulatory applications for UMEC/VI have been submitted and are undergoing assessment in a number of countries, including across the European Union and Japan.” gsk.com ↗ |
| Filed | Japan (PMDA) | Anoro Ellipta | COPD, severe early onset | — | “In April 2013, a regulatory submission for UMEC/VI under the trade name Anoro Ellipta was filed in Japan” gsk.com ↗ |
| Filed | US (FDA) | Anoro Ellipta | COPD, severe early onset | — | “a New Drug Application (NDA) was submitted to the FDA for the use of UMEC/VI” gsk.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT02487446 | Jul 2015 → Sep 2016 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | Missed primary |
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 2018-04-18 | GlaxoSmithKline | Results Landmark IMPACT study published in NEJM shows significant benefits of Trelegy Ellipta for patients with COPD gsk.com ↗
A statistically significant 34% reduction in COPD hospitalisations (severe exacerbations) for Trelegy compared to Anoro (0.13 vs. 0.19 per year; p<0.001) and a reduction of 13% compared to Relvar/Breo which was not statistically significant (0.13 vs. 0.15; p=0.064). |
| 2017-11-01 | GlaxoSmithKline | Results GSK study demonstrates superiority of Anoro Ellipta to Stiolto Respimat in improving lung function in chronic obstructive pulmonary disease gsk.com ↗
This endpoint was met and, furthermore, UMEC/VI demonstrated superiority to TIO/OLO, with a difference in treatment effect of 52mL on trough FEV1 at week eight (UMEC/VI 180mL vs. TIO/OLO 128mL; 95% CI: 28, 77; p<0.001). |
| 2016-05-18 | GlaxoSmithKline | Results GSK presents efficacy data for Anoro® Ellipta® in COPD patients who remained symptomatic on tiotropium gsk.com ↗
These efficacy data demonstrate the improvement in lung function that can be achieved in patients with moderate COPD when changing treatment from monotherapy with tiotropium 18mcg to dual bronchodilation with Anoro Ellipta. |
| 2015-09-27 | GlaxoSmithKline | Results GSK presents post-hoc analysis of Anoro® Ellipta® data assessing markers of COPD deterioration compared to tiotropium or placebo using a novel composite endpoint gsk.com ↗
The results of the analysis showed that the risk of experiencing a clinically important deterioration was significantly lower for patients on UMEC/VI 62.5/25mcg once daily compared to tiotropium 18mcg once daily (hazard ratio: 0.62; 95% confidence interval [CI]: 0.54, 0.71; p<0.001) or placebo (hazard ratio: 0.37; 95% CI: 0.30, 0.45; p<0.001) in an intention to treat population, based on analysis of time to first deterioration. |
| 2014-05-08 | GlaxoSmithKline | Regulatory Anoro® (umeclidinium/vilanterol) gains marketing authorisation in Europe for the treatment of COPD gsk.com ↗
today announced that the European Commission has granted marketing authorisation for Anoro® (umeclidinium/vilanterol) as a once-daily, maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). |
| 2014-03-14 | GlaxoSmithKline | Results GSK and Theravance announce positive results from studies comparing ANORO™ ELLIPTA™ with SERETIDE® DISKUS® and ADVAIR® DISKUS® in patients with COPD gsk.com ↗
UMEC/VI achieved a statistically significant improvement in lung function |
| 2014-02-20 | GlaxoSmithKline | Regulatory Anoro® (umeclidinium / vilanterol) receives positive opinion from the CHMP in Europe for the treatment of COPD gsk.com ↗
today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorisation for umeclidinium/vilanterol (UMEC/VI) |
| 2013-12-18 | GlaxoSmithKline | Regulatory ANORO™ ELLIPTA™ approved as first once-daily dual bronchodilator for the treatment of COPD in the US gsk.com ↗ |
| 2013-09-10 | GlaxoSmithKline | Regulatory FDA Advisory Committee recommends approval in US of umeclidinium/vilanterol for the treatment of COPD gsk.com ↗ |
All press releases naming this drug 20 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Umeclidinium/vilanterol | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02487446 ↗ |
| Known as | UMEC/VI | “PURPOSE: To compare the efficacy and safety of two long-acting dual bronchodilator combinations: indacaterol/glycopyrrolate (IND/GLY) versus umeclidinium/vilanterol (UMEC/VI).” PMID 28993871 ↗ Oct 2017 |
| Known as | Umeclidinium Bromide/Vilanterol | “Dual Bronchodilation with Indacaterol Maleate/Glycopyrronium Bromide Compared with Umeclidinium Bromide/Vilanterol in Patients with Moderate-to-Severe COPD: ” PMID 28993871 ↗ Oct 2017 |
| Route | Inhaled | “Umeclidinium/vilanterol 62.5/25 ug via inhalation once daily” NCT02487446 ↗ |