AstraZeneca announced that Breztri Aerosphere (budesonide/ glycopyrronium/ formoterol fumarate), formerly PT010, has been approved in Japan as a triple-combination therapy to relieve symptoms of chronic obstructive pulmonary disease (COPD).
This is the first global regulatory approval for Breztri Aerosphere and is the first approval by the Japanese Ministry of Health, Labour and Welfare for a triple-combination therapy in a pressurised metered-dose inhaler (pMDI), which uses the innovative Aerosphere delivery technology.
The approval was based on positive results from the phase III KRONOS trial in which Breztri Aerosphere demonstrated a statistically-significant improvement in trough forced expiratory volume in one second (FEV1), the primary endpoint for Japan, compared with the dual comparators Bevespi Aerosphere (glycopyrronium/formoterol fumarate) and PT009 (budesonide/formoterol fumarate).
Breztri Aerosphere (budesonide/glycopyrronium/ formoterol fumarate), formerly known as PT010, is a single-inhaler, fixed-dose triple combination of budesonide, an inhaled corticosteroid, glycopyrronium, a long-acting muscarinic agonist, and formoterol fumarate, a long-acting beta2-agonist.
Under the terms of the agreement to acquire Pearl Therapeutics Inc., AstraZeneca anticipates making a US$ 150 million milestone payment upon US regulatory approval of Breztri for COPD. This payment would be the final development and regulatory milestone under that agreement.