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(Alliance News) - AstraZeneca PLC on Wednesday said it is well-placed to transform current asthma emergency treatment approaches, after its inhaler was recommended by the US Food & Drug Administration.
The Cambridge, England-based biopharmaceutical company is developing PT027 with Avillion LLP.
PT027 is a pressurised metered-dose inhaler, fixed-dose combination rescue medication, containing albuterol and budesonide.
The FDA's Pulmonary-Allergy Drugs Advisory Committee voted 16 to 1 that the data supports a favourable benefit risk assessment for the use of PT027 for the treatment of asthma in people aged 18 years or older.
However, for children aged 12 to 17 years old, the committee voted 9 to 8 against a favourable benefit risk assessment.
Even fewer members supported the use of PT027 in children aged 4 to 11 years old, voting 16 to 1 against.
Bradley Chipps, the former president of the American College of Allergy, Asthma & Immunology, said that PT027 could "transform the current rescue treatment approach".
He noted that while millions of people with asthma rely on their albuterol rescue inhaler to alleviate acute symptoms, it "does not treat the underlying inflammation", which puts patients at risk of "severe" exacerbations.
PT027 is a combination, rather than single-dose, rescue medication.
It is the first and only rescue medication recommended for US approval that has been shown to reduce severe exacerbations.
"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," said Mene Pangalos, executive vice-president of the Respiratory & Immunology department at AstraZeneca.
"We look forward to working with our partner Avillion and the FDA to progress the application and discuss next steps, including for adolescents and children."
AstraZeneca shares were trading 0.7% higher at 10,734.00 pence each in London on Wednesday morning.
By Holly Beveridge; hollybeveridge@alliancenews.com
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