FDA issues CRL for PT010 filing in COPD

AstraZeneca (LSE: AZN) saw its shares fall 1.45% to £71.56 by late morning after it announced a delay in the US approval process for its triple combination therapy for chronic obstructive pulmonary disease (COPD).

The US Food and Drug Administration has issued a complete response letter (CRL) regarding the New Drug Application (NDA) for PT010 (budesonide/glycopyrronium/formoterol fumarate), an inhaled triple-combination therapy and potential new medicine for patients with COPD.

The NDA submitted to the FDA by Anglo-Swedish pharma major included data from the Phase III trial KRONOS. The company says it 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.