AstraZeneca has confirmed that budesonide / glycopyrronium / formoterol fumarate has been approved for chronic obstructive pulmonary disease (COPD) rehabilitation treatment in China. This is the National Medical Products Administration’s first certification for a triple-combination therapy in a pressurized metered-dose inhaler (pMDI), using the revolutionary delivery system from Aerosphere.
The approval requires a priority analysis and is based on the results of the Phase III KRONOS study in which PT010 reported a statistically significant improvement in China’s primary endpoint for forced expiratory volume in one second (FEV1) relative to dual-combination therapies Bevespi PT009 (budesonide / formoterol fumarate) and aerosphere (glycopyrronium / formoterol fumarate).
PT010’s protection and tolerability is compatible with the dual comparator’s known profiles. KRONOS study results were released in October 2018 in The Lancet Respiratory Medicine.
Mene Pangalos, BioPharmaceuticals R&D Executive Vice President, said: “Chronic obstructive pulmonary disease affects nearly 100 million people in China and is a leading cause of morbidity and mortality. With this certification, we can now offer patients for whom new treatments are desperately needed a powerful new triple-combination therapy.
Our triple-combination therapy is delivered in a pressurized metered-dose inhaler, an essential tool choice for clinicians and patients in China. “Professor Wang Chen, President of the China National Clinical Research Center for Respiratory Diseases, Chairman of the Chinese-Japan Friendship Hospital Respiratory Disease Center and Chinese National Lead Investigator of the KRONOS Study, said:”
In the KRONOS research, budesonide / glycopyrronium / formoterol fumarate provided significant and lasting changes in lung function in patients with mild to very severe disease. “Budesonide / glycopyrronium / formoterol fumarate was approved as a triple-combination therapy to alleviate COPD symptoms in Japan in June 2019 as Breztri Aerosphere. The drug, under the code PT010, is also under FDA scrutiny in the US and EU.
AstraZeneca, China