Biopharmaceutical company AstraZeneca Plc (LON:AZN) announced on Wednesday the approval of Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate), formerly PT010, in Japan as a triple-combination therapy to relieve symptoms of chronic obstructive pulmonary disease (COPD).

According to the company, 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.

This 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).

Also, the Chinese National Medical Products Administration has granted a priority review to Breztri Aerosphere, with an expected regulatory decision in the second half of 2019. This medicine is also under regulatory review in the US and EU with anticipated regulatory decisions in 2020.

AstraZeneca added that under the terms of the agreement to acquire Pearl Therapeutics Inc, it anticipates making a USD150m milestone payment upon US regulatory approval of Breztri for COPD. This payment would be the final development and regulatory milestone under that agreement.

AstraZeneca is focused on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in the therapy areas of Oncology, Cardiovascular, Renal & Metabolism and Respiratory.