AstraZeneca and Avillion Receive the US FDA’s Approval of Airsupra (PT027) for the Treatment of Asthma
Shots:
- The US FDA has approved Airsupra (albuterol/budesonide) for as-needed treatment or prevention of bronchoconstriction & to reduce the risk of exacerbations in patients with asthma aged ≥18yrs.
- The approval was based on the P-III trial (MANDALA) & (DENALI) evaluating PT027 vs albuterol in 3132 & 1001 adults and children aged 4-11yrs. Both trials met their 1EPs i.e., reductions in risk of sev. exacerbations over albuterol, when used as a rescue medicine in response to symptoms in (MANDALA) trial, added ICS alone or in combination with asthma maintenance therapies
- In the (DENALI) trial, lung function improved as measured by FEV1 over albuterol & budesonide. The safety & tolerability in both trials were consistent with the known profiles
Ref: PRNewswire | Image: AstraZeneca
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