Posted by Michael Wonder on 31 May 2022
US FDA accepts new drug application filed by Avillion for AstraZeneca's PT027 for the as needed treatment or prevention of symptoms in asthma patients
31 May 2022 - Results from Phase 3 trials conducted by Avillion in over 4,000 patients show that PT027, a novel fixed-dose combination of albuterol and budesonide, significantly reduced the risk of a severe asthma exacerbation compared to albuterol alone.
Avillion announces that the US FDA has accepted for filing Avillion's new drug application for AstraZeneca's PT027.
The proposed indication is for the as needed treatment or prevention of bronchoconstriction and for the prevention of exacerbations in patients with asthma 4 years of age and older.
