(CercleFinance.com) – AstraZeneca announces that the Food and Drug Administration’s (FDA) Pulmonary Allergy Drug Advisory Committee (PADAC) has issued a favorable evaluation (16 votes against 1) on the risk/benefit ratio PT027 (albuterol/budesonide) as a treatment for asthma in people aged 18 years and over.
In contrast, in adolescents aged 12 to 17 years, the committee voted 9 to 8 that the data did not support a favorable benefit/risk assessment for the use of PT027 as a treatment for asthma.
Similarly, in children aged 4 to 11 years, the committee voted 16 to 1 that the data did not support a favorable benefit/risk assessment of PT027.
AstraZeneca recalls that PT027 is a pressurized metered-dose inhaler (pMDI) containing the short-acting beta2-agonist (SABA) albuterol and the inhaled anti-inflammatory corticosteroid (ICS) budesonide.
In the first half of 2022, the FDA accepted the New Drug Application (NDA) for PT027 and set a date for the Prescription Drug User Fee Act for the first half of 2023.
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