AstraZeneca PLC said its triple-combination therapy Breztri Aerosphere received U.S. approval for treating a group of lung diseases called chronic obstructive pulmonary disease.
The medicine was approved as a maintenance therapy, which is meant to either complement a main treatment or be used as a follow-up. Breztri Aerosphere, or PT010, is a combination of budesonide, glycopyrrolate and formoterol fumarate, delivered through a pressurized metered-dose inhaler.
The U.S. Food and Drug Administration — which rejected the therapy in 2019 — based its approval on the results of two late-stage trials — called Ethos and Kronos — in which the drug was found to be better at treating patients when compared to other treatments, including AstraZeneca's very own dual combo therapy Bevespi Aerosphere, or PT009.
In December 2019, China's National Medical Products Administration approved Breztri Aerosphere for treating COPD. The regulator also approved Bevespi Aerosphere for treating the same indication in May.