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.