Respiratory - September 2020
CAR-T Digest - August 2020
CAR-T Digest - August 2020
CAR-T Digest - August 2020
CAR-T Digest - August 2020
Respiratory - September 2020
Breztri Aerosphere approved in the US for the maintenance treatment of COPD
Enerzair Breezhaler (QVM149; Mometasone furoate, glycopyrronium bromide and indacaterol acetate, ICS/LAMA/LABA) – Novartis
07 Jul 2020
- European Commission (EC) approved Enerzair Breezhaler as maintenance treatment of Asthma in adult patients not adequately controlled with a maintenance combination of a long‑acting beta2‑agonist (LABA) and a high-dose of an inhaled corticosteroid (ICS) who experienced one or more Asthma exacerbations in the previous year
- Once-daily Enerzair Breezhaler is the first LABA/long-acting muscarinic antagonist (LAMA)/ICS fixed-dose combination available in the EU for these patients
- The approval also includes an optional digital companion with sensor and app that provides inhalation confirmation, medication reminders and access to objective data to better support therapeutic decisions
- The EC approval is based on robust efficacy and safety data from over 3,000 Asthma patients in the Phase III IRIDIUM study
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10 Jul 2020
- Phase 3 IRIDIUM data published in Lancet Respiratory Medicine
- The primary endpoint was met, with both high- and medium-doses of Enerzair Breezhaler demonstrating statistically significant improvement in trough FEV1 ([0.065 L; p<0.001] and [0.076 L; p<0.001], respectively) compared to the corresponding doses of IND/MF at Week 26
- The key secondary endpoint was improvement in ACQ-7 score for Enerzair Breezhaler versus IND/MF. Both treatments delivered clinically meaningful improvements in this measure of symptoms from baseline at Week 26, but the key secondary endpoint was not met
- Once-daily Enerzair Breezhaler 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
- In secondary analyses, improvements in lung function were observed with high- and medium-dose IND/GLY/MF compared to high-dose Sal/Flu
- In other secondary analyses, clinically meaningful reductions in moderate-to-severe (36%) and severe (42%) Asthma exacerbation rates were observed with high-dose IND/GLY/MF compared to high-dose Sal/Flu
- Enerzair Breezhaler is approved in EU, Japan and Canada, and is currently under regulatory review in other countries
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07 Sep 2020
- Post hoc analysis shows high-dose Enerzair Breezhaler reduces Asthma exacerbations versus medium-dose, complementing key pivotal IRIDIUM study findings
- High-dose, once-daily Enerzair Breezhaler reduced Asthma exacerbation rates by 21% (moderate or severe) and 31% (severe) versus medium-dose, over 52 weeks
- This data supports the data from pivotal IRIDIUM study
- This is the first long-acting beta2-agonist (LABA)/ long-acting muscarinic antagonist (LAMA)/ inhaled corticosteroid (ICS) fixed-dose combination approved for patients whose Asthma is uncontrolled with a LABA/ICS
- Results:
- Moderate-or-severe Asthma exacerbations: reduced by 21% (p=0.026)
- Severe exacerbations: reduced by 31% (p=0.003)
- High dose composition reduced the annualized rate of all exacerbations (mild, moderate and severe) by 14% (p=0.132) compared with medium-dose, but this finding was not statistically significant
- Both the doses have favorable safety and tolerability profile
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Novartis’ Enerzair Breezhaler approved in EU
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CI Scientists Remarks:
- The PLATINUM clinical development program
- A Phase 3/3b clinical development program supporting the development of Enerzair Breezhaler and Atectura Breezhaler that includes four studies (N=>7500):
- QUARTZ – compared a low-dose of IND/MF with MF alone
- PALLADIUM – compared IND/MF with MF and salmeterol xinafoate/fluticasone propionate (Sal/Flu)
- IRIDIUM – compared IND/GLY/MF with IND/MF and Sal/Flu
- ARGON – compared IND/GLY/MF with a free combination of Sal/Flu plus tiotropium (Tio)
- A Phase 3/3b clinical development program supporting the development of Enerzair Breezhaler and Atectura Breezhaler that includes four studies (N=>7500):
- Novartis has two major approvals for Asthma in this quarter:
- Triple therapy Enerzair Breezhaler in EU (launch by end of year) , Japan and Canada – It’s a sensor and an app
- Two-drug Atectura Breezhaler in EU
- About Enerzair Breezhaler –
- It’s a sensor and app. A transparent capsule lets users see the medication; the inhaler also includes an attached CE marked sensor that connects with Propeller’s smartphone app
- Novartis collaborated with Propeller Health to use their digital medication-tracking platform along with Enerzair Breezhaler in Europe and Japan
- Propeller’s app also delivers medication reminders to the user and tracks adherence data, which can then be shared with clinicians
– Dr. Kowndinya, CI Scientists