AstraZeneca Wins FDA Approval for COPD Treatment


The U.S. Food and Drug Administration (FDA) gave the green light to AstraZeneca for a new chronic obstructive pulmonary disease (COPD) treatment.

This morning, AstraZeneca announced the approval of the triple-therapy Breztri Aerosphere as a maintenance treatment for COPD. Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) was approved based on positive results from the Phase III ETHOS study. In that late-stage study, Breztri Aerosphere 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 Breztri Aerosphere in the trial were consistent with the known profiles of the dual comparators.

The approval was also supported by efficacy and safety data from the Phase III KRONOS trial. During that trial, AstraZeneca’s data showed that Breztri Aerosphere outperformed its dual therapy rivals eight of nine times. In the KRONOS trial, AstraZeneca pitted Breztri Aerosphere against Bevespi Aerosphere (glycopyrronium/formoterol fumarate), Symbicort Turbuhaler (budesonide/formoterol fumarate) and its investigational PT009 (budesonide/formoterol fumarate) in patients with moderate to very severe COPD regardless of whether or not they had an exacerbation in the prior year.

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In both trials, the safety and tolerability of Breztri Aerosphere were consistent with the profiles of the dual comparators.

“Breztri Aerosphere has demonstrated a strong clinical profile compared with dual-combination therapies and offers a meaningful new treatment option for patients. Chronic obstructive pulmonary disease is a debilitating progressive condition and the fourth leading cause of death in the US. We look forward to discussing all-cause mortality data from the Breztri Aerosphere ETHOS trial with health authorities,” Mene Pangalos, AstraZeneca’s head BioPharmaceuticals R&D, said in a statement.

The FDA initially rejected the medication for approval in October when AstraZeneca sought approval based primarily on data from the KRONOS study. At the time the ETHOS trial had not yet been completed. Results from the two Phase III studies have been published in The New England Journal of Medicine and the Lancet Respiratory Medicine.

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. About 30 to 40 percent of moderate to severe COPD patients on triple inhaled therapy remain uncontrolled and continue to experience exacerbations. Respiratory drugs have been a key focus for AstraZeneca, particularly since the $575 million acquisition of Takeda Pharmaceutical Company’s core respiratory business, including global rights to roflumilast, a treatment for COPD.

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