AstraZeneca’s triple-combination therapy approved in China for patients with COPD

AstraZeneca

23 December 2019 - First fixed-dose triple-combination therapy in a pressurised metered-dose inhaler device in China.

AstraZeneca today announced that budesonide/glycopyrronium/formoterol fumarate has been approved in China for the maintenance treatment of chronic obstructive pulmonary disease (COPD).

This is the first approval by the National Medical Products Administration for a triple-combination therapy in a pressurised metered-dose inhaler (pMDI), which uses the innovative Aerosphere delivery technology.

The approval follows a priority review and is based on results from the Phase III KRONOS trial in which PT010 demonstrated a statistically significant improvement in trough forced expiratory volume in one second (FEV1), the primary endpoint for China, compared with dual-combination therapies Bevespi Aerosphere (glycopyrronium/formoterol fumarate) and PT009 (budesonide/formoterol fumarate).

Read AstraZeneca press release

Michael Wonder

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Michael Wonder