According to Avillion, the FDA has accepted the company’s NDA for AstraZeneca’s PT027 albuterol/budesonide MDI for the treatment of asthma in patients aged 4 and older for review. In March 2018, Avillion announced that it was partnering with Pearl Therapeutics on development of PT027; Pearl was acquired by AstraZeneca in 2013. AstraZeneca has an option to commercialize PT027 in the US if the inhaler is approved.
In September 2021, AstraZeneca announced positive results from two Phase 3 trials of PT027, MANDALA and DENALI. According to the announcement, Avillion has agreed to fund an additional Phase 3b trial, BATURA.
Avillion CEO Allison Jeynes commented, “Our clinical studies have demonstrated the strong potential of PT027 in providing a meaningful contribution to patient care in asthma, and we’re pleased to be making this NDA filing and reaching a key milestone in what continues to be an excellent partnership with AstraZeneca. Throughout our various clinical co-development collaborations, Avillion has maintained a 100% trial success rate across multiple therapy areas, and the evolution of our model to include regulatory filing responsibilities further demonstrates the strong value we can provide to partner companies. We’re excited to continue working with AstraZeneca as PT027 progresses through the regulatory process, and as we prepare to launch the BATURA study as part of an expansion to the partnership.”
Read the Avillion press release.
