New Medicines

Atectura Breezhaler (UK), Bemrist Breezhaler (EU)Uncontrolled asthma - add-on therapy


Atectura Breezhaler (UK), Bemrist Breezhaler (EU)
New formulation

Development and Regulatory status

November 2020
Nov 20Launched in the UK. Price: 125 microgram/62.5 microgram inhaler=£17.49; 125 microgram/127.5 microgram inhaler=£21.50 and 125 microgram/260 micrograms inhaler=£27.97 [13].
Oct 20Sandoz will be marketing Atectura in the UK [12].
May 20Atectura/Bemrist Breezhalers approved in EU for use as a maintenance treatment of asthma in adults and adolescents 12 years of age and older not adequately controlled with inhaled corticosteroids and inhaled short-acting beta2-agonists [11].
Mar 20Recommended for EU approval by CHMP for treatment of asthma (formal indication details yet to be published) [9].
May 19for review by the EMA [6].
Dec 18No change to planned filing date [5].
Dec 16Filings now expected 2019 [3].
Dec 15PIII. Filing planned for 2018 [1].


Fixed dose combination preparation of indacaterol (long-acting beta 2 agonist) and mometasone furoate (inhaled cortiocosteroid)
5.4 million people in the UK receive treatment for asthma: 1 in 10 children and 1 in 12 adults.
Uncontrolled asthma - add-on therapy

Trial or other data

Jul 20PIII PALLADIUM study (n=2216) is published; once-daily fixed combination of mometasone furoate (MF) plus indacaterol acetate (MF-IND) improved lung function versus MF monotherapy and high-dose MF-IND was non-inferior to twice-daily high-dose fluticasone–salmeterol for improvement in trough FEV1 [10].
Oct 19Positive topline results announced from PIII PALLADIUM study (N=2216, NCT02554786) of inhaled once-daily QMF149 (Indercaterol and mometasone 150/160 µg and 150/320 µg doses via Breezhaler®) vs. mometasone 400 µg and 800 µg via Twisthaler® in pts with asthma uncontrolled on medium or high dose ICS or low dose LABA/ICS. The study also included a secondary comparison of high dose IND/MF via Breezhaler® vs. twice daily salmeterol xinafoate/fluticasone propionate (50/500 µg) via Accuhaler®. QMF149 was reported to have demonstrated superior improvement in trough FEV1 after 26 weeks vs. mometasone furoate, meeting primary endpoint. IND/MF was generally well tolerated, and safety was comparable across treatment arms [7].
May 19QMF149 met its primary and key secondary endpoints in the PIII QUARTZ trial (NCT02892344). This multicentre, randomised, double-blind study assessed the efficacy and safety of QMF149 (150/80 Mcg) vs. mometasone furoate (200mcg) via the Twisthaler® device in 802 adult and adolescent pts with asthma over 12 weeks. All pts had suffered with Asthma for ~ 14 yrs and were inadequately controlled on a stable low dose ofICS (+/- LABA) for >1 month prior to entering the run-in period where they all received ICS. Pts were randomided (1:1) to receive either IND/MF once daily via Breezhaler® device (n=398) or MF once daily via Twisthaler® (n=404). The primary objective was to demonstrate superiority of IND/MF vs. in terms of trough FEV1 after 12 weeks. The key secondary objective was to demonstrate the superiority of IND/MF vs. MF in terms of Asthma Control Questionnaire (ACQ)-7 after 12 weeks. ND/MF demonstrated statistically significant improvements in lung function measured by trough FEV1 vs. MF after 12 weeks [Least squares (LS) mean treatment difference: 0.182 L, 95% CI: 0.148, to 0.217; p < 0.001]. Clinically meaningful lung function benefit for IND/MF was supported by improvements in PEF of 26.1 L/min vs. MF alone (95% CI, 21.0, 31.2). Clinically meaningful improvement in ACQ-7 was supported by a responder analysis, in which the QMF149 group had more responders vs. MF group (74.7% vs 64.9%, odds ratio: 1.69, 95% CI: 1.23, 2.33). Both treatments (IND/MF and MF) were generally well tolerated with incidence of adverse events lower in the IND/MF vs. MF group (32.3% vs. 38.3%) [6].
Dec 18A PIII study to evaluate the long-term safety of indacaterol/mometasone in patients with inadequately controlled asthma (NCT03100500) completed collection of the primary outcome in July 2018. Results are not yet reported [4].
Oct 18NCT02554786 is currently recruiting patients. Collection of the primary outcome is estimated to complete November 18 [4].
Nov 15Novartis is planning to conduct a PIII trial to compare safety and efficacy of indacaterol/mometasone with mometasone furoate in patients with asthma (NCT02554786). The randomised, double-blind, triple dummy, parallel-group, 52-week trial is intended to enrol 2,800 patients in the EU. Primary outcome FEV1; collection of data should complete Apr 18 [2].

Evidence based evaluations