AstraZeneca COPD drug finally gets OK from FDA, inching closer to GSK leader
Almost a year ago, AstraZeneca’s triple-drug combination for chronic obstructive pulmonary disease was shot down with an FDA complete response letter. But on Friday, it finally received the green light.
The UK pharma giant has received approval for its Breztri Aerosphere, formerly dubbed PT010, culminating the drug’s bumpy regulatory journey in a win. Now, AstraZeneca can challenge the leader in the area — GlaxoSmithKline’s Trelegy — without obstacle.
Originally, Breztri Aerosphere faced concerns from the results of its KRONOS trial. Despite demonstrating positive topline results, the inhaler drug failed to significantly distinguish itself from two of AstraZeneca’s other dual-combo therapies in the rate of moderate or severe COPD exacerbations.
But AstraZeneca returned to regulators with results from the more recent ETHOS study, which had not been completed when the pharma originally submitted the NDA. That exacerbation rate served as ETHOS’ primary endpoint as opposed to KRONOS, which measured lung function parameters.
“Preventing exacerbations is central to the management of chronic obstructive pulmonary disease,” said Fernando Martinez, lead investigator of the ETHOS trial, in a statement. “Even a single exacerbation can have a negative impact on a patient’s lung function and quality of life, and it can increase the risk of death.”
Full results from ETHOS, released last August, indicated that both standard and half doses of the therapy’s budesonide agent resulted in statistically significant reductions in those COPD exacerbations. Additionally, ETHOS was a 52-week trial whereas KRONOS was 24 weeks.
Breztri Aerosphere had previously received a regulatory OK in Japan with numbers from the KRONOS study, but the FDA was not satisfied.
The therapy itself combines its previous dual-combination treatments into what AstraZeneca has said is a better way for patients to individually calibrate their dosage levels. In addition to the inhaled corticosteroid budesonide, Breztri Aerosphere utilizes a LAMA (glycopyrronium) and a LABA (formoterol fumarate).
Given the approval, GSK could face some stiffer competition in the COPD market. Trelegy is also a triple-combo therapy and raked in about $660 million in 2019 sales, with almost three-quarters of that amount coming from US purchases. As the respiratory field shifts toward triple-drug combinations and away from dual- and monotherapy treatments, AstraZeneca is looking to take a chunk of that pie.