PT 027 recommended by FDA advisory committee as a new rescue treatment for asthma in people aged 18 years and older.- AstraZeneca + Avillion
The FDA's Pulmonary-Allergy Drugs Advisory Committee (PADAC) has voted 16 to 1 that the data support a favourable benefit risk assessment for the use of PT 027 (albuterol/budesonide) for the treatment of asthma in people aged 18 years and older
In adolescents aged 12 to 17 years, the Committee voted 9 to 8 that the data do not support a favourable benefit risk assessment for the use of PT 027 for the treatment of asthma. In children aged 4 to 11 years, the Committee voted 16 to 1 that the data do not support a favourable benefit risk assessment for the use of PT 027 for the treatment of asthma.
PT 027 is a potential first-in-class, pressurised metered-dose inhaler (pMDI), fixed-dose combination rescue medication in the US containing albuterol, a short-acting beta2-agonist (SABA), and budesonide, an anti-inflammatory inhaled corticosteroid (ICS). It is being developed by AstraZeneca and Avillion.
In the first half of 2022, the FDA accepted the New Drug Application (NDA) for PT027 and set a Prescription Drug User Fee Act date for the first half of 2023.
The NDA submission was based on results from the MANDALA, DENALI and TYREE Phase III trials In MANDALA, PT 027 significantly reduced the risk of severe exacerbations compared to albuterol in patients with moderate to severe asthma when used as an as-needed rescue medication in response to symptoms. In DENALI, PT 027 significantly improved lung function compared to the individual components, albuterol and budesonide, in patients with mild to moderate asthma.
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