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FDA Advisory Committee recommends PT027 in asthma
FDA Advisory Committee recommends PT027 in asthma.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \n \n 9 November 2022 07:00 GMT\n \n \n \n \n \n \n PT027 recommended by FDA advisory committee as new rescue treatment for asthma\n \n \n \n \n \n \n \n First and only rescue medication recommended for US approval that has been shown to reduce severe exacerbations\n \n \n \n \n \n \n \n \n The Food and Drug Administration's (FDA) Pulmonary-Allergy Drugs Advisory Committee (PADAC) has voted 16 to 1 that the data support a favourable benefit risk assessment for the use of PT027 (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 PT027 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 PT027 for the treatment of asthma. \n \n \n \n \n \n PT027 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.\n \n \n \n \n \n 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.\n \n \n \n \n \n \n \n Bradley E. Chipps, Past President of the American College of Allergy, Asthma & Immunology and Medical Director of the Capital Allergy & Respiratory Disease Center in Sacramento, US, said: \"Millions of people with asthma rely on their albuterol rescue inhaler to alleviate acute symptoms, but this does not treat the underlying inflammation, leaving patients at risk of severe asthma exacerbations, regardless of their disease severity or level of control. If approved, PT027 could transform the current rescue treatment approach.\"\n \n \n \n \n \n Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: \"We are pleased that the Pulmonary-Allergy Drugs Advisory Committee has recognised the potential for PT027 to deliver important benefits for people with asthma, as a first-in-class treatment option in the US. We look forward to...