AstraZeneca announced the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) rejecting the New Drug Application (NDA) for PT010 (budesonide/glycopyrronium/formoterol fumarate), an inhaled triple-combination therapy 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 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.
PT010 was approved in Japan in June 2019 as Breztri Aerosphere, a triple-combination therapy to relieve symptoms of COPD. PT010 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.
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ATHENA is PT010’s global clinical trial program, including 11 completed Phase III trials with more than 15,500 patients. The four key trials are ETHOS, KRONOS, TELOS and SOPHOS. The ETHOS and KRONOS trials assessed the efficacy and safety of PT010. The TELOS and SOPHOS trials characterized PT009 and substantiated it as an active comparator in the PT010 clinical trial program.
In the Phase III ETHOS trial, PT010 demonstrated a statistically-significant reduction in the rate of moderate or severe exacerbations compared with dual-combination therapies Bevespi Aerosphere (glycopyrronium/formoterol fumarate) and PT009 (budesonide/formoterol fumarate). The safety and tolerability of PT010 in the trial were consistent with the known profiles of the dual comparators.
PT010 is a fixed-dose triple-combination of budesonide, an inhaled corticosteroid with glycopyrronium, a long-acting muscarinic agonist, and formoterol fumarate, a long-acting beta2-agonist, delivered in a pressurized metered-dose inhaler.
Under the terms of the agreement to acquire Pearl Therapeutics, AstraZeneca anticipates making a $150m milestone payment upon US regulatory approval of PT010 for COPD. This payment would be the final development and regulatory milestone under that agreement.
COPD is a progressive disease which can cause obstruction of airflow in the lungs resulting in debilitating bouts of breathlessness. It affects an estimated 384 million people worldwide and is predicted to be the third leading cause of death by 2020.