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

pharmafile | December 23, 2019 | News story | Sales and Marketing AstraZeneca, COPD, China, respiration 

AstraZeneca has announced that budesonide-glycopyrroniunm-formoterol fumarate has been approved in China for the maintenance treatment of chronic obstructive pulmonary disease (COPD). It is under the name PT010.

This approval follows a review based on the results of a Phase 3 trial, in which PT010 demonstrated a statistically significant improvement in trough forced expiratory volume in one second, compared with dual-combination therapies.

This data was published in The Lancet Respiratory Medicine in October 2018, and showed the safety and tolerability of the treatment was consistent with the known profiles of the dual comparators.

The Chinese approval for PT010 follows a priority review designated for treatments that utilise advanced dosage technology, innovative treatment measures or clinical treatment advantage.

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “Chronic obstructive pulmonary disease affects almost 100 million people in China, and is a leading cause of morbidity and mortality. With this approval, we are now able to provide a powerful new triple-combination therapy to patients for whom new treatments are critically needed.”

AstraZeneca anticipates making a $150 million milestone payment upon US regulatory approval of PT010 for COPD.

COPD is a progressive disease which can cause obstruction of airflow in the lungs resulting in debilitating bouts of breathlessness. It affects an estimated 384 million people worldwide and approximately 100 million people in China. It is predicted to be the third leading cause of death globally by 2020.

Conor Kavanagh

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