Drugs / QVA149
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | Ultibro | chronic obstructive pulmonary disease | 2015-11-12 | “Also filed for approval in China Ultibro®1 (LAMA/LABA; Development code: QVA149)” nxera.life ↗ |
| Filed | EU (EMA) | — | chronic obstructive pulmonary disease | 2012-10-25 | “QVA149の第Ⅲ相臨床試験IGNITEプログラムの最初の５つの試験 (ILLUMINATE、SHINE、SPARK、ENLIGHTENおよびBRIGHT試験)のデータを基にEMAに対し承認 申請を行いました。” nxera.life ↗ |
| Filed | US (FDA) | — | chronic obstructive pulmonary disease | — | “Demandes d'autorisation pour LCZ696 déposées aux Etats-Unis et dans l'UE et pour QVA149 et NVA237 aux Etats-Unis” novartis.com ↗ “Zulassungsanträge für LCZ696 in den USA und der EU sowie für QVA149 und NVA237 in den USA eingereicht” novartis.com ↗ “Files submitted for LCZ696 in US and EU, and for QVA149 and NVA237 in US” novartis.com ↗ “Submissions to US FDA complete for QVA149 and NVA237 in Q4 2014” novartis.com ↗ “Submissions to US FDA complete for QVA149 and NVA237 in Q4 2014” nxera.life ↗ “U.S. FDA filing acceptance of NDAs for QVA149 and NVA237” nxera.life ↗ |
Trials 12
News releases announcing trial results or a regulatory action · 55
| Date | Issuer | Release |
|---|---|---|
| 2018-02-22 | Nxera Pharma UK Limited | Results Treatment with Ultibro Breezhaler improved cardiac function in COPD patients with lung hyperinflation nxera.life ↗
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 treatment1. |
| 2017-11-28 | Nxera Pharma UK Limited | Results New data showed Ultibro Breezhaler significantly improved COPD patients’ lung function after direct switch from Seretide nxera.life ↗
The study met the primary endpoint demonstrating that switching patients to Ultibro ® Breezhaler® resulted in significantly improved lung function (trough FEV1)1. |
| 2017-11-27 | Novartis Pharmaceuticals | Results Novartis' Ultibro® Breezhaler® significantly improved COPD patients' lung function after direct switch from Seretide® novartis.com ↗
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]. |
| 2016-12-09 | Nxera Pharma UK Limited | Results Ultibro Breezhaler improved lung function and COPD symptoms after direct switch from previous treatment nxera.life ↗ |
| 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]. |
| 2016-05-16 | Nxera Pharma UK Limited | Results Other nxera.life ↗ |
| 2016-05-16 | Nxera Pharma UK Limited | Results Major study published in NEJM confirms Ultibro Breezhaler superiority over Seretide in preventing COPD exacerbations nxera.life ↗
In addition to meeting the primary endpoint (non-inferiority), findings demonstrated the superiority of Ultibro Breezhaler over the widely used inhaled corticosteroid (ICS)/LABA* combination on exacerbation outcomes 1. |
| 2016-05-15 | Novartis Pharmaceuticals | Results Major study published in NEJM confirms Novartis' Ultibro® Breezhaler® superiority over Seretide® in preventing COPD exacerbations novartis.com ↗
In addition to meeting the primary endpoint (non-inferiority), findings demonstrated the superiority of Ultibro Breezhaler over the widely used inhaled corticosteroid (ICS)/LABA* combination on exacerbation outcomes[1]. |
| 2015-11-17 | Novartis Pharmaceuticals | Results FLAME study shows superiority of Novartis' Ultibro® Breezhaler® over Seretide® in reducing COPD exacerbations novartis.com ↗ |
| 2015-11-17 | Nxera Pharma UK Limited | Results Other nxera.life ↗ |
| 2015-10-30 | Nxera Pharma UK Limited | Regulatory Other nxera.life ↗
FDA は、第Ⅲ相臨床試験の EXPEDITION 臨床試験 プログラムのデータ に基づき Utibron Neohaler を承認しました。 |
| 2015-10-30 | Nxera Pharma UK Limited | Regulatory Sosei confirms FDA approvals of new dual combination bronchodilator Utibron Neohaler and monotherapy Seebri Neohaler for patients with chronic obstructive pulmonary disease nxera.life ↗
Sosei confirms FDA approvals of new dual combination bronchodilator Utibron™ Neohaler® and monotherapy Seebri™ Neohaler® for patients with chronic obstructive pulmonary disease |
| 2015-05-21 | Nxera Pharma UK Limited | Results Other nxera.life ↗ |
| 2015-05-21 | Nxera Pharma UK Limited | Results Two positive US phase III programs in COPD for QVA149 and NVA237 nxera.life ↗
QVA149 improved lung function, breathlessness and health-related quality of life in moderate-to-severe COPD patients, according to EXPEDITION trial results1-7 |
| 2015-05-20 | Novartis Pharmaceuticals | Results Novartis announces two positive US phase III programs in COPD for QVA149 and NVA237 novartis.com ↗
Data from the EXPEDITION program demonstrated that QVA149, administered twice-daily, improved lung function (FEV 1 AUC 0-12h ) compared to placebo and its individual monocomponents, indacaterol and glycopyrronium bromide (p<0.001), after 12 weeks of treatment, meeting its primary objective[1]-[2]. |
| 2015-03-06 | Nxera Pharma UK Limited | Regulatory Other nxera.life ↗ |
| 2015-03-06 | Nxera Pharma UK Limited | Regulatory U.S. FDA filing acceptance of NDAs for QVA149 and NVA237 nxera.life ↗
U.S. FDA filing acceptance of NDAs for QVA149 and NVA237 |
| 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. |
| 2015-01-08 | Nxera Pharma UK Limited | Regulatory Other nxera.life ↗ |
| 2015-01-08 | Nxera Pharma UK Limited | Regulatory Sosei confirms the submission of regulatory applications to US FDA and robust Phase III results for QVA149 and NVA237 nxera.life ↗
Submissions to US FDA complete for QVA149 and NVA237 in Q4 2014 |
| 2014-09-08 | Nxera Pharma UK Limited | Results Other nxera.life ↗ |
| 2014-09-08 | Nxera Pharma UK Limited | Results Positive results from three clinical trials presented at ERS 2014 further confirmed efficacy of Ultibro Breezhaler and Seebri Breezhaler, and promotion agreement with Pfizer in the UK nxera.life ↗ |
| 2014-05-21 | Nxera Pharma UK Limited | Results Other nxera.life ↗ |
| 2014-05-21 | Nxera Pharma UK Limited | Results Positive results at ATS for once-daily Ultibro Breezhaler versus combination therapy (tiotropium plus formoterol) nxera.life ↗ |
| 2014-04-30 | Nxera Pharma UK Limited | Results Other nxera.life ↗ |
| 2014-04-30 | Nxera Pharma UK Limited | Results Once-daily Ultibro Breezhaler showed superior efficacy versus Seretide for COPD patients in second head-to-head study, and the anticipated timing of China filing nxera.life ↗
Ultibro Breezhaler met both the primary and key secondary objectives. |
| 2013-09-23 | Nxera Pharma UK Limited | Regulatory Other nxera.life ↗ |
| 2013-09-23 | Nxera Pharma UK Limited | Regulatory First in class once-daily dual bronchodilator Ultibro Breezhaler (QVA149) approved for the treatment of COPD in Europe nxera.life ↗
First in class once-daily dual bronchodilator Ultibro® Breezhaler® (QVA149) approved for the treatment of COPD in Europe |
| 2013-09-20 | Nxera Pharma UK Limited | Regulatory Other nxera.life ↗ |
| 2013-09-20 | Nxera Pharma UK Limited | Regulatory First in class once-daily dual bronchodilator Ultibro Inhalation Capsules (QVA149) approved for the treatment of COPD in Japan nxera.life ↗ |
| 2013-09-09 | Nxera Pharma UK Limited | Results Other nxera.life ↗ |
| 2013-09-09 | Nxera Pharma UK Limited | Results Data at ERS further demonstrates efficacy of once-daily Ultibro Breezhaler (QVA149) and Seebri Breezhaler (glycopyrronium bromide) nxera.life ↗
New analyses in the IGNITE clinical trial program showed that QVA149 provided superior, rapid and sustained improvements in lung function and significantly reduced shortness of breath versus comparator therapies1,2 |
| 2013-08-26 | Nxera Pharma UK Limited | Regulatory Other nxera.life ↗ |
| 2013-08-26 | Nxera Pharma UK Limited | Regulatory First in class once-daily dual bronchodilator QVA149 gains endorsement for approval from Drug Committee of MHLW (Ministry of Health, Labour and Welfare) for the treatment of COPD in Japan nxera.life ↗
First in class once-daily dual bronchodilator QVA149 gains endorsement for approval from Drug Committee of MHLW (Ministry of Health, Labour and Welfare) for the treatment of COPD in Japan |
| 2013-07-27 | Nxera Pharma UK Limited | Regulatory Other nxera.life ↗ |
| 2013-07-27 | Nxera Pharma UK Limited | Regulatory First in class once-daily dual bronchodilator Ultibro Breezhaler (QVA149) gains positive CHMP opinion for the treatment of COPD nxera.life ↗
QVA149 (indacaterol/glycopyrronium) is the first once-daily fixed-dose combination of both a LABA and a LAMA bronchodilator to gain positive CHMP opinion |
| 2013-05-22 | Nxera Pharma UK Limited | Results Other nxera.life ↗ |
| 2013-05-22 | Nxera Pharma UK Limited | Results New data reinforces strength of once-daily COPD portfolio in improving lung function, shortness of breath and reducing rate of exacerbations nxera.life ↗
The BLAZE study showed that after six weeks of treatment, QVA149 significantly improved patient self-reported shortness of breath during daily activities versus both placebo (p<0.001) and tiotropium 18 mcg (p=0.021) 1. |
| 2013-04-24 | Nxera Pharma UK Limited | Results Other nxera.life ↗ |
| 2013-04-24 | Nxera Pharma UK Limited | Results Seebri Breezhaler GLOW 5 and GLOW 6 Phase III studies meet primary endpoint, and data from QVA149 SPARK Phase III study published in a medical journal nxera.life ↗
It was also confirmed that data from the 64-week Phase III SPARK study have been published in the Lancet Respiratory Medicine. |
| 2012-11-07 | Nxera Pharma UK Limited | Regulatory Other nxera.life ↗ |
| 2012-11-07 | Nxera Pharma UK Limited | Regulatory QVA149 filed by licensing partner as a once-daily maintenance treatment for COPD in Japan nxera.life ↗
QVA149 filed by licensing partner as a once-daily maintenance treatment for COPD in Japan |
| 2012-10-25 | Nxera Pharma UK Limited | Regulatory Other nxera.life ↗ |
| 2012-10-25 | Nxera Pharma UK Limited | Regulatory QVA149 filed as a once-daily maintenance treatment for COPD in Europe nxera.life ↗
QVA149, (indacaterol maleate/glycopyrronium bromide) an investigational drug for chronic obstructive pulmonary disease (COPD) has been filed for marketing authorisation with the European Medicines Agency (EMA), triggering a $5 million milestone payment to Sosei. |
| 2012-09-03 | Nxera Pharma UK Limited | Results Other nxera.life ↗ |
| 2012-09-03 | Nxera Pharma UK Limited | Results Data at ERS shows efficacy of once-daily COPD portfolio versus comparators, further establishes dual-bronchodilator QVA149 nxera.life ↗ |
| 2012-08-30 | Nxera Pharma UK Limited | Results Other nxera.life ↗ |
| 2012-08-28 | Nxera Pharma UK Limited | Results QVA149 Phase III study meets primary endpoint in reducing exacerbations in COPD patients and filings in EU and Japan by end of year nxera.life ↗ |
| 2012-04-24 | Nxera Pharma UK Limited | Results Other nxera.life ↗ |
| 2012-04-24 | Nxera Pharma UK Limited | Results QVA149 ILLUMINATE Phase III COPD study meets primary endpoint and clarification of anticipated timing of US filings for NVA237 and QVA149 nxera.life ↗
All four QVA149 Phase III studies have now met their primary endpoints, including the latest, ILLUMINATE, a head-to-head study against Seretide®, demonstrating its strong potential to address the unmet needs of patients with chronic obstructive pulmonary disease (COPD). |
| 2012-04-02 | Nxera Pharma UK Limited | Results QVA149 phase III COPD studies met primary endpoints nxera.life ↗
The results of BRIGHT demonstrated that patients experienced significantly better exercise endurance versus placebo (p=0.006). |
| 2012-04-02 | Nxera Pharma UK Limited | Results Other nxera.life ↗ |
| 2009-09-16 | Nxera Pharma UK Limited | Results Other nxera.life ↗ |
| 2009-09-16 | Nxera Pharma UK Limited | Results QVA149 Phase II Data Presented at the European Respiratory Society Annual Meeting nxera.life ↗
One hundred and thirty-five patients with moderate to severe COPD completed the study with an observed clinically relevant mean improvement in trough FEV 1 between QVA149 and placebo on Day 7 of 226 mL. |
All press releases naming this drug 65 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 13 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | QVA149 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01860066 ↗ |
| Known as | QVA149A | “Comparison of Long-term Safety of the Combination Product QVA149A Against Placebo and Standard of Care Treatment in Chronic Obstructive Pulmonary Disease Patients With Moderate...” NCT01610037 ↗ |
| Modality | Other / unclassified | “The long-acting β2-agonist/long-acting muscarinic antagonist combination indacaterol/glycopyrronium (IND/GLY)” PMID 35144620 ↗ Feb 2022 |
| Route | Inhaled | “QVA149 110/50 μg hard non-gelatin capsule, inhalation/blister once a day via SDDPI” NCT01490125 ↗ |