Following the recent announcement (Tuesday 1 October) that the Food and Drug Administration (FDA) has issued a complete response letter for the New Drug Application (NDA) for PT010 (budesonide/glycopyrronium/formoterol fumarate);

Paul Jeng, Senior Pharma Analyst at GlobalData, a leading data and analytics company, offers his perspective:

“In an attempt to close the gap with chief chronic obstructive pulmonary disease (COPD) rival GlaxoSmithKline (GSK), AstraZeneca pushed to file an NDA for PT010 earlier this year on the basis of the single Phase III KRONOS trial, rather than wait for results from a second pivotal COPD trial. AstraZeneca will now need to return to the FDA with additional data in order to gain access to the US market with PT010, which is also approved as Breztri Aerosphere in Japan. The delay could be costly, as GSK continues to build its multi-year lead in triple-combination therapy for COPD with Trelegy Ellipta for patients with a history of moderate to severe exacerbations.

“In the KRONOS trial, PT010 hit on the majority of endpoints, but failed to improve on the rate of exacerbations versus PT009 and Symbicort. However, AstraZeneca allayed concerns with the announcement of positive results from the Phase III ETHOS trial in August, showing PT010 could significantly reduce the rate of exacerbations in patients with moderate to very severe disease. A resubmission with ETHOS data will likely bring PT010 across the finish line.

“Given the abundance of both dual and monotherapy maintenance treatments for patients with COPD, capturing market share in the fixed-dose triple therapy space will be a key commercial objective for AstraZeneca, particularly considering the uncertain future of its respiratory biologic Fasenra (benralizumab) following a pair of failed trials. Notably, the ETHOS study is the first time a triple-combination therapy has shown benefit at two inhaled corticosteroid doses, which would allow prescribers to personalize treatment for individual patients.”