The FDA has published notice of an online meeting of the Pulmonary-Allergy Drugs Advisory Committee (PADAC) to take place on November 8, 2022 for the purpose of discussing Avillion and AstraZeneca’s NDA (214070) for PT027 albuterol / budesonide MDI for the treatment of asthma in patients aged 4 and older. The agency accepted the NDA in May 2022.
According to the announcement, the docket number for public comments is FDA-2022-N-1946. All comments must be submitted by November 7, 2022; the committee will be provided with comments that are submitted by October 25; and anyone wishing to make an oral presentation at the meeting must submit a request by October 17, 2022.
Avillion announced in March 2018 that it had partnered with Pearl Therapeutics on development of PT027; AstraZeneca had acquired Pearl in 2013. In September 2021, AstraZeneca announced positive results from the MANDALA and DENALI Phase 3 trials of PT027.
Read the FDA notice in the Federal Register.
