The FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) voted 16 to 1 that the benefit of Avillion and AstraZeneca’s PT027 albuterol / budesonide MDI for the treatment of asthma in adults outweighs the risks. However, the committee voted 9 to 8 that the risk outweighs the benefits for adolescents aged 12 to 17 and voted 16 to 1 against the use of PT027 for children aged 4 to 11.
The Avillion / AstraZeneca NDA for PT027, which was accepted by the FDA in May 2022, was supported by data from the MANDALA and DENALI Phase 3 trials of PT027. AstraZeneca acquired PT027 developer Pearl Therapeutics in 2013, and Avillion partnered with Pearl on development of PT027 in 2018.
AstraZeneca Executive VP, BioPharmaceuticals R&D, Mene Pangalos commented, “We are pleased that the Pulmonary-Allergy Drugs Advisory Committee has recognized 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 working with our partner Avillion and the FDA to progress the application and discuss next steps, including for adolescents and children.”
Read the AstraZeneca press release.
