AstraZeneca has announced that its Breztri Aerosphere (PT010) budesonide / glycopyrrolate / formoterol fumarate MDI has been approved by the FDA for the treatment of COPD. The FDA had previously issued a complete response letter to AstraZeneca’s NDA for PT010 in the fall of 2019.
In August 2019, the company announced that the Phase 3 ETHOS trial of Breztri had met its primary endpoint; the original NDA submission did not include results from that trial. According to AstraZeneca, the approval now is based on data from both the ETHOS trial and the Phase 3 KRONOS trial.
AstraZeneca also noted that the approval of Breztri Aerosphere triggers a $150 million milestone payment, the final milestone agreed to as part of its 2013 acquisition of Pearl Therapeutics, which initially developed PT010.
The Chinese National Medical Products Administration (NMPA) approved Breztri Aerosphere in December 2019. The MDI has also been approved in Japan since June 2019, and a submission is under review in the EU.
Read the AstraZeneca press release.
