Indacaterol / Mometason (1) – Atectura Breezhaler®

• Clinical trials
  • The PALLADIUM trial was a 52-week registration trial designed to evaluate Atectura Breezhaler 125 μg/127.5 μg once daily (n = 439) and 125 μg/260 μg once daily (n = 445) compared with mometasone furoate 400 μg once daily (n = 444) or 800 μg daily (administered as 400 μg twice daily) (n = 442).
  • The QUARTZ study was a 12-week study evaluating Atectura Breezhaler 125 μg/62.5 μg once daily (n = 398) compared with mometasone furoate 200 μg once daily (n = 404).

Combinations of glucocorticoids with long-acting beta-2 agonists, Group 1, at Stage 3

• The Medicinal Products Sub-Committee, in its deliberations on determining the additional benefit of indacaterol / mometasone furoate and on updating the fixed-reimbursement group ‘Combinations of glucocorticoids with long-acting beta-2 agonists, Group 1’ in Tier 3, has concluded that the additional benefit of indacaterol/mometasone furoate is deemed not proven in accordance with Section 35a(1), fifth sentence, of SGB V.
• The legal consequence of the company’s decision not to submit a dossier at the relevant time is the determination that the additional benefit is not proven.
• morbidity
  • Atectura Breezhaler 125 μg/62.5 μg once daily showed a statistically significantly greater improvement in trough FEV1 and the ACQ-7 score (Asthma Control Questionnaire) in week 12 compared with baseline, as opposed to mometasone furoate 200 μg once daily.
  • At week 26, statistically significant improvements in trough FEV1 and the ACQ-7 score (Asthma Control Questionnaire) compared with mometasone furoate 400 μg once or twice daily, respectively (see Table 2 on page 5).
  • Atectura Breezhaler 125 μg/127.5 μg and 125 μg/260 μg once daily both resulted in a clinically significant reduction in the annual rate of moderate or severe exacerbations (secondary endpoint) compared with mometasone furoate 400 μg once or twice daily (see Table 2 on page 5).
  • The pooled analysis demonstrated that Atectura Breezhaler improved trough FEV1 by 43 ml (95% CI: 17; 69) and a reduction in the ACQ7 score of 0.091 (95% CI: 0.153; 0.030) at week 26, as well as a 22 % lower annual rate of moderate or severe asthma exacerbations (RR: 0.78; 95 % CI: 0.66; 0.93) compared with salmeterol/fluticasone; the rate of severe exacerbations was 26 % lower (RR: 0.74; 95 % CI: 0.61; 0.91).
• Side effects
  • Side effects (SEs) are listed according to MedDRA system organ classes (Table 1). The data on the frequency of SEs are based on the PALLADIUM study.

Courtesy translation only, please refer to the German original.