Glycopyrronium + indacaterol + mometasone

Unassigned

New Medicines

Enerzair, Zimbus · Asthma in adults (GINA 2015 ≥ step 4)

Information

Enerzair, Zimbus
New formulation
Novartis
Novartis

Development and Regulatory status

Approved (Licensed)
Approved (Licensed)
None
Jul 20 · Approved in EU [10].
Apr 20 · Recommended for EU approval by CHMP - the full indication is "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." An optional electronic sensor may also be co-packed with the product. The sensor will be attached to the base of the inhaler to collect data on the use of the inhaler by the patient and will send the data to an app on a smart phone or other suitable device. [9]
Jun 19 · Filed in EU, via centralised procedure [6].
Dec 18 · No change to planned filing date [5].
Dec 16 · Filings now expected 2019 [3].
Dec 15 · PIII. Filing planned for 2018 [1].

Category

Fixed dose combination preparation containing glycopyrronium (antimuscarinic), indacaterol (a long-acting beta 2 agonist) & mometasone (inhaled corticosteroid).
In the UK, 4.3 million adults receive treatment for asthma (~6,500 per 100,000 people). In 2013, ~65% of patients on at least an ICS/ LABA were uncontrolled [8].
Asthma in adults (GINA 2015 ≥ step 4)
Inhalation

Trial or other data

Jul 20 · PIII IRIDIUM study (n=3092) is published; once-daily combination of mometasone, indacaterol and glycopyrronium (MF–IND–GLY) was associated with superior improvements in trough FEV1 vs corresponding doses of MF-IND at week 26 (treatment difference 76mL medium dose and 65mL high dose; both p<0.001) [11].
Sep 19 · Novartis announced PIII (NCT02571777) IRIDIUM study met its primary end point. Glycopyrronium bromide/indacaterol/mometasone was superior to indacaterol/mometasone in improving trough FEV1 after 26 weeks. This improvement in lung function was achieved in asthma patients who were uncontrolled on treatment with a long-acting beta agonist/inhaled corticosteroid. Detailed results from the IRIDIUM trial will be presented at upcoming medical congresses [7].
Jul 18 · PIII (NCT02571777) is currently recruiting patients. Collection of primary outcome should now complete Jun 19 [4].
Dec 15 · PIII (NCT02571777) study to assess safety and efficacy of glycopyrrolate/indacaterol/mometasone vs. indacaterol/mometasone (QMF149) in patients with asthma. The randomised, active-controlled, double-blind trial is intended to enrol 3155 patients in Estonia, Germany, Lithuania and Thailand. Primary outcome is trough FEV1; collection of data is expected to complete Apr 18 [2].