The FDA issued a complete response letter to AstraZeneca for its NDA for PT010 — a three drug combination product for treatment of chronic obstructive pulmonary disease (COPD).
AstraZeneca studied the safety and efficacy of the budesonide/glycopyrronium/formoterol fumarate treatment in two phase 3 clinical trials, Kronos and Ethos. The Kronos trial, on which the NDA was based, showed that the drug provided a statistically significant improvement in six out of seven combination therapies compared with dual combination therapies.
The Ethos trial — in which PT010 demonstrated a statistically-significant reduction in the rate of moderate or severe exacerbations compared with other dual-combination therapies — was not completed at the time the NDA was submitted.
The company said it will submit recent results of the Ethos trial to the agency for review and will work with the FDA on next steps.