The Food and Drug Administration has issued a complete response letter (CRL) to AstraZeneca regarding the Company’s New Drug Application (NDA) for PT010, an investigational triple combination therapy for chronic obstructive pulmonary disease (COPD).
PT010 is a single inhaler, fixed-dose triple combination therapy of budesonide, an inhaled corticosteroid with glycopyrronium, a long-acting muscarinic antagonist (LAMA), and formoterol fumarate, a long-acting beta2-agonist (LABA). The treatment is delivered via a pressurized metered-dose inhaler utilizing AstraZeneca’s AEROSPHERE Delivery Technology. The NDA submission included data from the phase 3 KRONOS trial, 1 of the 4 key trials assessing the efficacy and safety of the drug in patients with moderate to very severe COPD.
In a statement, AstraZeneca noted that at the time of regulatory submission, the ETHOS trial, also part of the global clinical program for PT010, had not been completed and therefore was not included in the NDA. Recently announced results from ETHOS showed that PT010 was associated with a statistically significant reduction in the rate of moderate or severe exacerbations when compared with glycopyrronium/formoterol and budesonide/formoterol fumarate. The Company plans to work with the FDA on next steps which include submission and review of the ETHOS trial data.
PT010 is currently approved in Japan under the brand name Breztri Aerosphere; it is also under regulatory review in the European Union.
For more information visit astrazeneca.com.