Drugs / indacaterol/glycopyrronium
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | chronic obstructive pulmonary disease | — | “QVA149 (indacaterol/glycopyrronium bromide) 27.5/12.5 mcg, administered twice daily, as used in the EXPEDITION program, has been submitted for US registration.” novartis.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 4 | NCT02576626 | Dec 2015 → Sep 2017 | chronic obstructive pulmonary disease | Wouter H. van Geffen | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2020-07-10 | Novartis Pharmaceuticals | Results Novartis Phase III IRIDIUM data in Lancet Respiratory Medicine show benefit of Enerzair® Breezhaler® (QVM149), the first-in-class inhaled LABA/LAMA/ICS combination in uncontrolled asthma novartis.com ↗
Once-daily Enerzair® Breezhaler® (QVM149; IND/GLY/MF) was superior to once-daily IND/MF (QMF149) in improving the lung function of patients whose asthma is uncontrolled with LABA/ICS standard-of-care treatment 1 |
| 2018-02-22 | Novartis Pharmaceuticals | Results Treatment with Novartis' Ultibro® Breezhaler® improved cardiac function in COPD patients with lung hyperinflation novartis.com ↗
The CLAIM study met its primary endpoint demonstrating that treatment with Ultibro Breezhaler led to decreased lung hyperinflation and improvements in cardiac function** after 14 days of treatment[1]. |
| 2017-11-27 | Novartis Pharmaceuticals | Results Novartis' Ultibro® Breezhaler® significantly improved COPD patients' lung function after direct switch from Seretide® novartis.com ↗
Basel, November 27, 2017 - Novartis today announced positive results from the FLASH** study examining the safety and efficacy of directly switching chronic obstructive pulmonary disease (COPD) patients from Seretide ® (salmeterol/fluticasone) 50/500 mcg to Ultibro ® Breezhaler ® (indacaterol/glycopyrronium) 110/50 mcg[1]. |
| 2017-05-23 | Novartis Pharmaceuticals | Results Novartis' new analyses reinforce the potential of Ultibro® Breezhaler® for COPD patients historically treated with steroids novartis.com ↗
The new analyses showed that once-daily Ultibro Breezhaler (indacaterol/glycopyrronium) 110/50 mcg was superior to twice-daily Seretide (salmeterol/fluticasone [SFC]) 50/500 mcg in reducing exacerbations (flare-ups), independent of a blood eosinophil count above or below 2%[1]. |
| 2016-12-08 | Novartis Pharmaceuticals | Results Novartis' Ultibro® Breezhaler® improved lung function and COPD symptoms after direct switch from previous treatment novartis.com ↗
In the CRYSTAL study, patients with moderate COPD who were switched to Ultibro Breezhaler from their previous therapy (LABA+ICS * or LABA or LAMA***) experienced superior improvements in lung function (trough FEV 1 ) and breathlessness**** at week 12 (p<0.0001). |
| 2016-09-03 | Novartis Pharmaceuticals | Results Novartis' Ultibro® Breezhaler® consistently more effective than Seretide®* in reducing COPD flare-ups across different patient groups novartis.com ↗
New analyses from the head-to-head FLAME study confirmed that Ultibro ® Breezhaler ® is a more effective option for patients at risk of chronic obstructive pulmonary disease (COPD) flare-ups (exacerbations) than Seretide ® , across different patient sub-groups[1-10]. |
| 2016-05-15 | Novartis Pharmaceuticals | Results Major study published in NEJM confirms Novartis' Ultibro® Breezhaler® superiority over Seretide® in preventing COPD exacerbations novartis.com ↗
The results of FLAME confirmed that Ultibro Breezhaler is superior to SFC in reducing exacerbation outcomes regardless of a patient's disease severity and eosinophil levels (a type of white blood cell)[1]. |
| 2015-11-17 | Novartis Pharmaceuticals | Results FLAME study shows superiority of Novartis' Ultibro® Breezhaler® over Seretide® in reducing COPD exacerbations novartis.com ↗
Once-daily Ultibro ® Breezhaler ® (indacaterol/glycopyrronium) 110/50 mcg met its primary endpoint (non-inferiority) and furthermore demonstrated superiority to twice-daily Seretide ® (salmeterol/fluticasone) 50/500 mcg in reducing the rate of all COPD exacerbations (mild/moderate/severe) over one year of treatment. |
| 2015-05-20 | Novartis Pharmaceuticals | Results Novartis announces two positive US phase III programs in COPD for QVA149 and NVA237 novartis.com ↗
Novartis announced today positive results from two pivotal Phase III clinical trial programs for QVA149 (indacaterol/glycopyrronium bromide) and NVA237 (glycopyrronium bromide) in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD). |
| 2015-01-08 | Novartis Pharmaceuticals | Results Novartis announces robust Phase III results for QVA149 and NVA237 and submits regulatory applications to US FDA novartis.com ↗
The results from the EXPEDITION (including FLIGHT 1, 2 and 3 studies) and GEM clinical trial programs met their primary and secondary endpoints. |
All press releases naming this drug 10 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 | indacaterol/glycopyrronium | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02576626 ↗ |