The US Food and Drug Administration (FDA)’s Pulmonary-Allergy Drugs Advisory Committee voted 16 to 1 in favor of the use of PT027 (albuterol/budesonide) for the treatment of asthma in those aged 18 years and over.
The combination treatment is a potential first-in-class rescue medication, after Phase III trials showed that PT027 significantly reduced the risk of severe exacerbations when used as an as-needed rescue medication in response to symptoms.
However, for adolescents aged 12 to 17 and in children aged 4 to 11, the FDA’s advisory committee voted against the treatment, concluding that the data did not support a favorable benefit risk assessment. In the former age group, the committee voted just 9 to 8 against approving the treatment and in the latter group, more comprehensively, 16 to 1 against.
Despite the knockback for adolescents and children, Mene Pangalos, EVP, BioPharmaceuticals R&D, AstraZeneca, said, “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.”
On receiving 16 to 1 backing in adults, it seems likely that PT027 will at least see approval for adults – though the agency is not duty-bound to follow through with the advice of the committee. A decision is expected by the first half of 2023.
AstraZeneca and Avillion partnered on the treatment in 2018, with the latter company being responsible for clinical development and financing through to regulatory approval.
In return, Avillion received undisclosed financial backing. On filing a new drug application (NDA) for the treatment, Avillion stated that following successful approval of PT027, AstraZeneca has the option, upon certain financial payments, to commercialize the treatment in the US.
The partnership between both companies was expanded to include a further Phase IIIb study to assess the role of PT027 in preventing asthma exacerbations.
The treatment itself contains albuterol, a short-acting beta2-agonist, and budesonide, an anti-inflammatory inhaled corticosteroid, which is delivered through a pressurized metered-dose inhaler.
According to Bradley Chipps, medical director of the Capital Allergy & Respiratory Disease Center in Sacramento, US, the combination of the two compounds could provide benefits over an albuterol rescue inhaler alone because it addresses the underlying inflammation. This could help provide control of severe asthma exacerbations.