Fixed combinations of Enerzair® and Atecura® may improve asthma treatment

New Fixed Dual and Triple Combinations

Atectura^® contains the long-acting β₂-agonist (LABA) indacaterol acetate (IND) and the inhaled corticosteroid (ICS) mometasone furoate (MF) in dosage combinations of 125/62.5 µg, 125/127.5 µg and 125/260 µg. Enerzair^® additionally contains the long-acting muscarinic antagonist (LAMA) glycopyrronium bromide in a dosage combination of 150/50/160 µg. Both preparations were evaluated in the PLATINUM clinical program, which included 4 studies.

Atectura^® Breezhaler^® – Results of the PALLADIUM Study

Atectura^® Breezhaler^® demonstrated significant improvement in the trough FEV₁ (forced expiratory volume in the first second), improvement in ACQ-7 questionnaire scores, and reduction in the occurrence of moderate to severe exacerbations after 26 weeks of treatment compared to mometasone furoate 400 µg once or twice daily in the randomized double-blind PALLADIUM study involving patients aged 12 and above with asthma uncontrolled by ICS or LABA maintenance therapy. The benefit persisted at the 52nd week of the study.

Enerzair^® Breezhaler^® – Results of the IRIDIUM Study

Enerzair^® Breezhaler^® was compared with Atectura^® Breezhaler^® 150/160 µg and 150/320 µg, and with the combination salmeterol xinafoate + fluticasone propionate (Sal/Flu) 50/500 µg in the multicenter randomized double-blind IRIDIUM study involving over 3,000 adult patients with asthma inadequately controlled on medium or high doses of LABA/ICS.

After 26 weeks, there was a significant increase in FEV₁ for both doses of Enerzair^® compared to Sal/Flu, which persisted at the 52nd week, indicating the long-term benefit of this drug in maintenance therapy. Improvement in FEV₁ compared to Sal/Flu and Atectura^® was evident 5 minutes post-administration. Enerzair^® also reduced the occurrence of moderate to severe exacerbations by 36% and severe exacerbations by 42% compared to Sal/Flu. The incidence of adverse events and serious adverse events was similar across all therapeutic arms.

Digital Aid

Enerzair^® is the first asthma treatment to incorporate a digital aid with the Breezhaler^® inhaler, including a dose sensor connected to an application. This allows for confirmation of inhalation, reminds for dose administration, and shares objective usage data with the physician.

Conclusion

In a situation where 45% of asthma patients in steps 4 and 5 of treatment remain inadequately controlled and methods to support proper use of anti-asthmatic treatments are being sought, new fixed combinations Atectura^® Breezhaler^® and Enerzair^® Breezhaler^® administered once daily (and in the latter case also with the option to use a digital aid) can facilitate cooperation between patients and physicians and help achieve therapeutic goals.

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Sources:
1. Novartis receives EC approval for Enerzair^® Breezhaler^®, including the first digital companion (sensor and app) that can be prescribed alongside a treatment for uncontrolled asthma in the EU. Press release. Novartis, 7. 7. 2020. 
2. Novartis Phase III IRIDIUM data in Lancet Respiratory Medicine show benefit of Enerzair^® Breezhaler^® (QVM149), the first-in-class inhaled LABA/LAMA/ICS combination in uncontrolled asthma. Press release. Novartis, 10. 7. 2020.
3. SPC Atectura Breezhaler. Available at: www.ema.europa.eu/en/documents/product-information/atectura-breezhaler-epar-product-information_cs.pdf
4. SPC Enerzair Breezhaler. Available at: www.ema.europa.eu/en/documents/product-information/enerzair-breezhaler-epar-product-information_cs.pdf