AstraZeneca's Combination Inhaler Shines In Phase 3 Asthma Trial

  • AstraZeneca Plc AZN posted full results from the positive MANDALA Phase 3 trial of PT027, an albuterol/budesonide fixed-dose combination rescue medication in patients with asthma.
  • The data exhibited that PT027 at two different strengths of budesonide demonstrated a statistically significant reduction in the risk of a severe exacerbation versus albuterol rescue.
  • Compared with albuterol rescue, PT027 at the 180mcg albuterol/160mcg budesonide dose reduced the risk of a severe exacerbation by 27%.
  • In secondary endpoints, PT027 (180mcg albuterol/160mcg budesonide) demonstrated a 33% reduction in mean annualized total systemic corticosteroid exposure and a 24% reduction in annualized severe exacerbation rate.
  • A numerically higher odds of patients experienced improved symptom control and quality of life after 24 weeks of treatment with PT027 than albuterol rescue.
  • PT027 at a lower budesonide dose (180mcg albuterol/80mcg budesonide) also demonstrated a statistically significant reduction of 17% in the risk of severe exacerbation versus albuterol rescue.
  • Price Action: AZN shares are up 1.97% at $64.39 during the market session on the last check Monday.
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