Novartis receives CHMP positive opinion for Enerzair Breezhaler

Novartis announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Enerzair® Breezhaler® (QVM149; indacaterol acetate, glycopyrronium bromide and mometasone furoate [IND/GLY/MF]) 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 year.

Novartis announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Enerzair® Breezhaler® (QVM149; indacaterol acetate, glycopyrronium bromide and mometasone furoate [IND/GLY/MF]) 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 year.

If approved, this will be the first once-daily LABA/long-acting muscarinic antagonist (LAMA)/ICS fixed-dose combination for these patients. The European Commission (EC) reviews the CHMP recommendation and usually delivers its final decision in approximately two months.

“This is an important development for patients with uncontrolled asthma because IND/GLY/MF has been shown to improve lung function and symptoms versus a LABA/ICS standard-of-care,” said Professor Huib Kerstjens, Head, Department of Pulmonology at the University Medical Center Groningen. “In secondary analyses of the Phase III IRIDIUM study statistically significant 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.”

IND/GLY/MF will be administered via the dose-confirming Breezhaler® device, which enables once-daily inhalation using a single inhaler. If approved, IND/GLY/MF will be the first asthma treatment in the EU that can be prescribed together with a digital companion; a Propeller Health sensor and app custom-built for the Breezhaler® device. This 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.

“Today’s news is a key milestone in our journey to reimagine asthma care by bringing innovative medicines and a digital companion to patients with uncontrolled asthma,” said Linda Armstrong, MD, Respiratory Development Unit Head, Novartis Pharmaceuticals. “Once-daily IND/GLY/MF has the potential to improve asthma control for patients whose lives are still impacted by their disease, despite existing inhaled therapies. Additionally, we are pleased to bring an innovative sensor and app companion supplied with IND/GLY/MF to patients to help support enhanced adherence.”

The CHMP recommendation is based on robust efficacy and safety data from over 3,000 patients with asthma from the Phase III IRIDIUM study, in which IND/GLY/MF demonstrated statistically significant improvements in lung function compared with indacaterol acetate/mometasone furoate (IND/MF).1

In the IRIDIUM study, the key secondary endpoint was improvement in Asthma Control Questionnaire score (ACQ-7) 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 met. Among other secondary analyses, IRIDIUM explored asthma exacerbation rates, where statistically significant reductions were observed in moderate-to-severe and severe asthma exacerbation rates with IND/GLY/MF compared with an established LABA/ICS standard-of-care (twice-daily salmeterol xinafoate/fluticasone propionate). Safety findings were consistent with the known safety profiles of the monocomponents.1

Last month the CHMP also recommended the approval of Atectura® Breezhaler® (IND/MF) as a maintenance treatment of asthma for adults and adolescents 12 years of age and older not adequately controlled with inhaled corticosteroids and inhaled short-acting beta-agonists.2 Novartis is committed to bringing IND/GLY/MF and IND/MF to patients, with additional regulatory filings currently underway in multiple countries, including Switzerland, Japan and Canada.

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.

Enerzair® Breezhaler® (QVM149; IND/GLY/MF) is intended as a maintenance treatment of asthma in adult patients not adequately controlled with a maintenance combination of a long‑acting beta2‑agonist and a high dose of an inhaled corticosteroid who experienced one or more asthma exacerbations in the previous year. This formulation combines the bronchodilation of indacaterol acetate (a LABA) and the antimuscarinic effects of glycopyrronium bromide (a LAMA) with mometasone furoate (high-dose 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 U.S.).

The sensor for the Breezhaler® device was developed by Propeller Health and is a CE marked Medical Device, designed and licensed to Novartis exclusively 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.

Atectura® Breezhaler® (QMF149; IND/MF) is the combination of indacaterol acetate and mometasone furoate intended as a maintenance treatment of asthma in adults and adolescents 12 years of age and older not adequately controlled with ICS and inhaled short-acting beta-agonists. IND/MF combines the bronchodilation of indacaterol acetate (a LABA) with the anti-inflammatory mometasone furoate (an ICS) in a precise once-daily formulation, delivered via the dose-confirming Breezhaler® device. Mometasone furoate is exclusively licensed to Novartis from a subsidiary of Merck & Co., Inc, Kenilworth, NJ, USA, for use in IND/MF.

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