Atectura® and Enerzair®: new fixed dual and triple combination in the treatment of bronchial asthma
In mid-2020, the European Commission approved two new fixed combinations of drugs by Novartis for patients with uncontrolled asthma – the dual combination Atectura® (LABA+ICS) and the triple combination Enerzair® (LABA+LAMA+ICS) for inhalation once daily using the Breezhaler® inhaler.
Atectura® (LABA+ICS)
The fixed dual combination Atectura® approved in the EU on May 20, 2020, is intended for the maintenance treatment of patients over 12 years old with bronchial asthma inadequately controlled by inhaled corticosteroids (ICS) and short-acting beta2-agonists (SABA). It contains the long-acting beta2-agonist (LABA) indacaterol acetate (IND) with bronchodilatory effects and ICS mometasone furoate (MF) with anti-inflammatory effects. Dose combinations of 150/80 µg, 150/160 µg, and 150/320 µg will be available. The product was approved based on the results of the QUARTZ study, which compared a low dose of IND/MF with MF alone, and the PALLADIUM study, where IND/MF was compared with the combination of salmeterol xinafoate + fluticasone propionate.
Enerzair® (LABA+LAMA+ICS)
On July 3, 2020, the fixed triple combination Enerzair® was approved in the EU, containing LABA indacaterol acetate + the long-acting muscarinic antagonist (LAMA) glycopyrronium bromide together with a high dose of ICS mometasone furoate. It is indicated for the maintenance treatment of adult patients with bronchial asthma inadequately controlled on LABA/ICS maintenance treatment and who experienced at least 1 exacerbation in the past year. The registration was granted based on robust data on the efficacy and safety of Enerzair® Breezhaler® in the IRIDIUM study.
Together with Enerzair®, an optional digital companion with a sensor connected to an app was also approved, allowing for the confirmation of inhalation, reminders for dosing, and objective monitoring of treatment adherence.
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Sources:
1. Novartis receives EC approval for Enerzair® Breezhaler®, including the first digital companion (sensor and app) prescribed alongside a treatment for uncontrolled asthma in the EU. Press release. Novartis, July 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, July 10, 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
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