July 10, 2020
Novartis today announced that full results from the Phase III IRIDIUM study were published in The Lancet Respiratory Medicine. The primary endpoint results show that once-daily treatment with high- and medium-dose Enerzair® Breezhaler® (QVM149; indacaterol acetate, glycopyrronium bromide and mometasone furoate [IND/GLY/MF]) demonstrated statistically significant improvements in lung function compared with once-daily QMF149 (indacaterol acetate and mometasone furoate [IND/MF])1.
The key secondary endpoint was improvement in Asthma Control Questionnaire (ACQ-7) score for IND/GLY/MF versus IND/MF. Although both treatments delivered clinically meaningful improvements in this measure, the key secondary endpoint was not met1. In secondary analyses, improvements in lung function and clinically meaningful reductions in moderate-to-severe and severe asthma exacerbation rates were observed with high-dose IND/GLY/MF compared to high-dose salmeterol xinafoate/fluticasone propionate (Sal/Flu)1.
“The IRIDIUM data show that once-daily treatment with a combination of IND/GLY/MF has the potential to improve lung function and reduce exacerbations in people who continue to experience symptoms despite receiving a LABA/ICS, which is the standard-of-care,” said Professor Huib Kerstjens, Head, Department of Pulmonology at the University Medical Center Groningen. “These data are encouraging because achieving optimal symptom control in asthma remains challenging; at least 45% of patients at GINA steps 4 and 5 remain uncontrolled, which can lead to reduced quality of life, decreased work productivity, and increased emergency or hospital-based medical care.”
The primary endpoint was met, with both high- and medium-doses of IND/GLY/MF 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 261.The key secondary endpoint was improvement in ACQ-7 score for IND/GLY/MF 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 met1.
At Novartis, we are working to reimagine respiratory treatment by bringing innovative medicines and digital solutions to patients,” said Dominic Brittain, Respiratory Global Program Head, Novartis Pharmaceuticals. “There have been relatively few developments in inhaled asthma treatment options over the last decade, so it’s exciting to see IND/GLY/MF show its potential as a once-daily, fixed-dose combination for the treatment of uncontrolled asthma in this pivotal study.”
In secondary analyses, improvements in lung function (FEV1) were observed for both doses of IND/GLY/MF versus high-dose Sal/Flu at Week 26 (high-dose [0.119 L; p<0.001]; medium-dose [0.099 L; p<0.001]). Similar FEV1 improvements were seen across all comparisons at Week 52, indicating the potential long-term benefits of this maintenance medicine. Improvements in post-dose FEV1 were seen with both doses of IND/GLY/MF as early as five minutes after initial drug administration, versus respective doses of IND/MF and high-dose Sal/Flu (p<0.001), indicating rapid onset of action1.
In further secondary analyses, substantial reductions in moderate-to-severe (36%; p<0.001) and severe (42%; p<0.001) asthma exacerbation rates were observed for high-dose IND/GLY/MF compared to high-dose Sal/Flu. Reductions in moderate-to-severe (19%; p=0.041) and severe (16%; p=0.117) asthma exacerbation rates were also seen with medium-dose IND/GLY/MF compared with high-dose Sal/Flu1.
The IRIDIUM study assessed IND/GLY/MF, a once-daily, fixed-dose combination of a long-acting beta2-agonist (LABA), a long-acting muscarinic antagonist (LAMA) and an inhaled corticosteroid (ICS) in high (150/50/160 µg) and medium (150/50/80 µg) doses versus IND/MF (LABA/ICS) in corresponding high (150/320 µg) and medium (150/160 µg) doses, in asthma patients not adequately controlled on current inhaled therapies, over 52 weeks of active treatment1.The overall incidence of adverse events (AEs) and serious adverse events (SAEs) for IND/GLY/MF and IND/MF in the IRIDIUM study were generally low and comparable among treatment groups. Asthma exacerbation was the most commonly reported AE and SAE1.
To date, medium- and high-doses of IND/GLY/MF have been approved in Japan, and high-dose IND/GLY/MF has been approved in the EU and Canada; these submissions were supported by the IRIDIUM study1,2. Additionally, IND/MF has received regulatory approval in the EU and Canada; these submissions were supported by the PALLADIUM study (also published in The Lancet Respiratory Medicine)3. Further regulatory reviews for both products are currently underway in multiple countries.In keeping with the Novartis commitment to reduce the environmental impact of our asthma combinations, IND/GLY/MF and IND/MF will both be available in the Breezhaler® device which is hydrofluoroalkane/chlorofluorocarbon (HFA/CFC)-free.
About Enerzair Breezhaler in the EU
On July 7, 2020, Novartis announced European Commission (EC) approval of Enerzair Breezhaler (QVM149; IND/GLY/MF) 150/50/160 μg once-daily as a 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 year2. This formulation combines the bronchodilation of indacaterol acetate (a LABA) and the antimuscarinic effects of glycopyrronium bromide (a LAMA) with mometasone furoate (ICS) in a precise once-daily formulation, delivered via the dose-confirming Breezhaler device.
Glycopyrronium bromide certain use and formulation intellectual property were exclusively licensed to Novartis in April 2005 by Sosei Heptares and Vectura. Mometasone furoate is exclusively licensed to Novartis from a subsidiary of Merck & Co., Inc, Kenilworth, NJ, USA, for use in IND/GLY/MF (worldwide excluding the US).
IND/GLY/MF will be administered via the dose-confirming Breezhaler device, which enables once-daily inhalation using a single inhaler. IND/GLY/MF is the first asthma treatment in the EU that can be prescribed together with a digital companion; the Propeller Health app and sensor custom-built for the Breezhaler device. The digital companion will provide patients with inhalation confirmation, medication reminders and access to objective data that can be shared with their physician in order to help them make better therapeutic decisions.
The sensor for the Breezhaler device was developed by Propeller Health and is a CE marked Medical Device, designed and licensed to Novartis for use with the Breezhaler inhaler worldwide. The sensor includes a microchip, a microphone, Bluetooth capabilities, an antenna and a battery. The sensor does not alter the drug delivery characteristics of the Breezhaler inhaler itself but produces a recording of each administered dose. Based on the patient’s recorded medication usage, personalized content is presented within the app to help the patient better self-manage their asthma.
Novartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 109,000 people of more than 145 nationalities work at Novartis around the world. Find out more at https://www.novartis.com.
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