Complete Response Letter for PT 101 triple therapy for COPD.- Astra Zeneca

AstraZeneca announced that the FDA has issued a complete response letter regarding the New Drug Application (NDA) for PT 010 (budesonide/glycopyrronium/formoterol fumarate), an inhaled triple-combination therapy and potential new medicine for patients with chronic obstructive pulmonary disease (COPD). The NDA submitted to the FDA by AstraZeneca included data from the Phase III trial KRONOS. The Company will now work closely with the FDA regarding next steps, including submitting for review recent results from the second positive Phase III trial, ETHOS, which was not completed at the time the NDA was submitted.

PT 010 was approved in Japan in June 2019 as Breztri Aerosphere, a triple-combination therapy to relieve symptoms of COPD. PT 010 is under regulatory review in China where it has been granted priority review by the National Medical Products Administration, and is also under regulatory review in the EU.

Comment:In 2017, Rival GSK launched a triple COPD therapy called Trelegy Ellipta, which had $200 million in sales last year and is expected to clear $500 million in 2019.