Drugs / QVM149
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | EU (EMA) | — | asthma | 2019-05-24 | “it has submitted a valid Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for QVM149, a potential new inhaled combination therapy for asthma.” nxera.life ↗ “QVM149 (ICS/LABA/LAMA) and QMF149 (ICS/LABA) were both filed with EMA for the treatment of asthma.” novartis.com ↗ “QVM149 について、医薬品販売承認（以下「MA A」」を欧州医薬品庁（EMA）へ申請したこと” nxera.life ↗ |
| Filed | Japan (PMDA) | — | asthma | — | “QVM149 has been submitted to the Japanese Pharmaceuticals and Medical Devices Agency (PMDA”)” nxera.life ↗ “QVM149 was submitted for registration in Europe in May 2019 and in Japan in Q3 2019.” nxera.life ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT03108027 | Jun 2017 → Feb 2018 | asthma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT03100825 | Apr 2017 → Sep 2018 | asthma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT03063086 Comparator | Jan 2017 → Aug 2018 | asthma | Novartis Pharmaceuticals | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 21
| Date | Issuer | Release |
|---|---|---|
| 2020-09-07 | Novartis Pharmaceuticals | Results Novartis post hoc analysis shows high-dose Enerzair® Breezhaler® reduces asthma exacerbations versus medium-dose, complementing key pivotal IRIDIUM study findings novartis.com ↗
High-dose, once-daily Enerzair ® Breezhaler ® [IND/GLY/MF] reduced asthma exacerbation rates by 21% (moderate or severe) and 31% (severe) versus medium-dose, over 52 weeks |
| 2020-09-07 | Nxera Pharma UK Limited | Results Sosei Heptares notes presentation of post hoc analysis showing high-dose Enerzair Breezhaler reduces asthma exacerbations versus medium-dose nxera.life ↗ |
| 2020-09-07 | Nxera Pharma UK Limited | Results Other nxera.life ↗ |
| 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 |
| 2020-07-10 | Nxera Pharma UK Limited | Results Sosei Heptares notes publication of Ph3 IRIDIUM data in The Lancet Respiratory Medicine showing benefit of Enerzair Breezhaler in uncontrolled asthma nxera.life ↗ |
| 2020-07-10 | Nxera Pharma UK Limited | Results Other nxera.life ↗ |
| 2020-07-07 | Novartis Pharmaceuticals | Regulatory Novartis receives EC approval for Enerzair® Breezhaler®, including the first digital companion (sensor and app) that can be prescribed alongside a treatment for uncontrolled asthma in the EU novartis.com ↗
European Commission approves once-daily Enerzair ® Breezhaler ® (QVM149; IND/GLY/MF) in the EU, the first-in-class LABA/LAMA/ICS fixed-dose combination for patients whose asthma is uncontrolled with LABA/ICS |
| 2020-07-07 | Nxera Pharma UK Limited | Regulatory Other nxera.life ↗ |
| 2020-07-07 | Nxera Pharma UK Limited | Regulatory Sosei Heptares notes Enerzair Breezhaler approval in the European Union as a treatment for uncontrolled asthma nxera.life ↗
European Commission approves once-daily Enerzair® Breezhaler® (QVM149; IND/GLY/MF) in the EU, the first-in-class LABA/LAMA/ICS fixed-dose combination for patients whose asthma is uncontrolled with LABA/ICS1 |
| 2020-06-05 | Novartis Pharmaceuticals | Results Novartis Phase IIIb ARGON study meets primary endpoint in a comparison of Enerzair® Breezhaler® (QVM149) versus a free combination of two existing inhaled treatments in uncontrolled asthma novartis.com ↗
Once-daily Enerzair ® Breezhaler ® (QVM149; IND/GLY/MF) met primary endpoint, demonstrating non-inferiority to a free combination of twice-daily Sal/Flu plus once-daily tiotropium (Tio), in improving quality of life in people with uncontrolled asthma 1 . |
| 2020-06-05 | Nxera Pharma UK Limited | Results Sosei Heptares notes Phase IIIb ARGON study with Enerzair Breezhaler (QVM149) meets primary endpoint in patients with uncontrolled asthma nxera.life ↗
Once-daily Enerzair® Breezhaler® (QVM149; IND/GLY/MF) met primary endpoint, demonstrating non-inferiority to a free combination of twice-daily Sal/Flu plus once-daily Tio in improving quality of life in people with uncontrolled asthma1 |
| 2020-06-05 | Nxera Pharma UK Limited | Results Other nxera.life ↗ |
| 2020-05-01 | Novartis Pharmaceuticals | Regulatory Novartis receives CHMP positive opinion for Enerzair® Breezhaler® (QVM149), a potential first-in-class inhaled LABA/LAMA/ICS combination for uncontrolled asthma novartis.com ↗ |
| 2020-05-01 | Nxera Pharma UK Limited | Regulatory Sosei Heptares notes that Enerzair Breezhaler (QVM149) has been recommended for approval in the European Union for treating uncontrolled asthma nxera.life ↗
Sosei Heptares notes that Enerzair® Breezhaler® (QVM149) has been recommended for approval in the European Union for treating uncontrolled asthma |
| 2020-05-01 | Nxera Pharma UK Limited | Regulatory Other nxera.life ↗
Enerzair® Breezhaler®（QVM149）がコントロール不良な喘息 の治療剤として 欧州連合の承認勧告を取得 |
| 2019-10-01 | Nxera Pharma UK Limited | Results Other nxera.life ↗ |
| 2019-10-01 | Nxera Pharma UK Limited | Results Sosei Heptares notes the announcement of positive results from Phase3 IRIDIUM study of inhaled combination QVM149 in patients with uncontrolled asthma nxera.life ↗
In meeting the primary endpoint, QVM149 was shown to be superior to QMF149 in improving trough forced expiratory volume in one second (FEV1) after 26 weeks. |
| 2019-09-30 | Novartis Pharmaceuticals | Results Novartis announces positive results from Phase III IRIDIUM study of inhaled combination QVM149 in patients with uncontrolled asthma novartis.com ↗
Once-daily QVM149 demonstrated statistically significant improvement in lung function versus QMF149, meeting primary endpoint[1],[2] |
| 2019-05-24 | Nxera Pharma UK Limited | Regulatory Sosei Heptares notes that a valid Marketing Authorization Application for QVM149 has been filed with the European Medicines Agency nxera.life ↗
Sosei Group Corporation (“the Company”; TSE: 4565) announces it has been notified today by its strategic alliance partner Novartis (SWX: NOVN) that it has submitted a valid Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for QVM149, a potential new inhaled combination therapy for asthma. |
| 2019-05-24 | Nxera Pharma UK Limited | Regulatory Other nxera.life ↗ |
| 2019-05-22 | Novartis Pharmaceuticals | Results Novartis phase II data for new inhaled combination treatment (QVM149) demonstrates significant improvements over current standard-of-care inhaled treatment novartis.com ↗
In two phase II clinical studies, IND/GLY/MF was superior to the comparators, salmeterol/fluticasone propionate (a standard-of-care treatment)[1] and placebo[2], separately by demonstrating improvement in lung function in patients with asthma. |
All press releases naming this drug 23 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | QVM149 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03100825 ↗ |
| Route | Inhaled | “QVM149 150/50/160 μg once daily, delivered as powder in hard capsules via Concept1 inhaler” NCT03100825 ↗ |