AstraZeneca announced that the FDA has approved Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) for the maintenance treatment of asthma in adults. The product was previously approved in the United States for the maintenance treatment of chronic obstructive pulmonary disease (COPD) and is now authorized for use in a second respiratory indication in the U.S.
The asthma approval is based on results from the Phase 3 KALOS and LOGOS trials, which evaluated Breztri in adults and adolescents with uncontrolled asthma on inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) therapy. In these studies, Breztri met the primary endpoints, demonstrating statistically significant improvements in lung function compared with ICS/LABA regimens. Key efficacy data from the trials supported the benefit of triple therapy with an inhaled corticosteroid, a long-acting muscarinic antagonist, and a long-acting beta2-agonist in this patient population.
Under the new U.S. label, Breztri is indicated as a maintenance therapy and is not intended for relief of acute bronchospasm. The approved dose for asthma is delivered via a pressurized metered-dose inhaler, taken as two inhalations twice daily. AstraZeneca stated that the safety profile of Breztri in asthma was consistent with the known safety profile of the individual components and with prior experience in COPD.
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