Shots:

• The P-III MANDALA & DENALI trial evaluates the efficacy & safety of PT027 (180/160mcg & 180/80mcg doses) vs albuterol & albuterol and budesonide aged ≥4yrs. in 3132 & 1001 patients with asthma
• Both trials met its 1EPs i.e.- reductions in risk of severe exacerbations in the MANDALA trial- improvement in lung function as measured by FEV1 in DENALI trials- safety & tolerability in both trials were consistent with the known profiles of the components
• PT027 is a fixed-dose combination of albuterol- SABA- budesonide & an inhaled ICS. The therapy is being developed by AstraZeneca and Avillion

| Ref: AstraZeneca | Image: PharmaLive