FDA Issues Complete Response Letter for AstraZeneca COPD Drug Application

October 1, 2019

AstraZeneca has received a complete response letter from FDA regarding its new drug application for a budesonide/glycopyrronium/formoterol fumarate triple-combination therapy for treating chronic obstructive pulmonary disease.

On Oct. 1, 2019, AstraZeneca announced that FDA has issued a complete response letter regarding a new drug application (NDA) the company submitted for PT010 (budesonide/glycopyrronium/formoterol fumarate), an inhaled triple-combination therapy and potential new medicine for patients with chronic obstructive pulmonary disease (COPD).

The NDA included data from a Phase III trial. The company will now work closely with FDA regarding the next steps, including submitting recent results from a second positive Phase III trial for review, which was not completed at the time the NDA was submitted.

PT010 was approved in Japan in June 2019 as Breztri Aerosphere for treating COPD and is under regulatory review in China, where it has been granted priority review by the National Medical Products Administration. It is also under regulatory review in the European Union.

Meanwhile, under the terms of an agreement to acquire Pearl Therapeutics Inc., AstraZeneca anticipates making a $150-million milestone payment upon US regulatory approval of PT010 for COPD. The payment would be the final development and regulatory milestone under that agreement.

Source: AstraZeneca