AstraZeneca plc (ADR) (NYSE:AZN) has announced that its Phase 3 study of Bevespi has demonstrated significant improvement in lung function in patients suffering from mild to chronic obstructive pulmonary disease (COPD).
The company reported significant progress from the Phase 3 PINNACLE 4 study which involved more than 1,700 patients from various regions including the United States, Asia, and Europe. The patients in the clinical study received daily regimens of Bevespi Aerosphere that were administered twice every day through pMDI. The drug registered significant improvement in patients compared to the placebo. AstraZeneca also revealed that it measured the lung function improvement using forced expiratory volume in one second (FEV1).
“Bevespi Aerosphere is a fixed dose combination of glycopyrrolate -a long-acting muscarinic antagonist (LAMA) and formoterol fumarate- long-acting beta2-adrenergic agonist in a pressurized metered dose inhaler (pMDI), which is approved for the long-term maintenance treatment of airflow obstruction in COPD,”
AstraZeneca plans to use the findings of the Phase 3 PINNACLE 4 study as well as the results of previous studies to file for regulatory approval in Japan and China. The company launched Bevespi in the U.S in January 2017 and so far the company reported inhaler sales at $4 million within the first half of the year. The treatment is currently under review by the EU and it is pending approval.
The recent findings from the Phase 3 trials are great news for the company because they strengthen the company’s application for review. Submission of these new findings will most likely speed up the review process. Bevespi Aerosphere is on its way to joining the list of LAMA treatments that have been approved by the FDA over the past few years.
Some of the companies whose LABA/LAMA combination treatments have been approved by the FDA include GlaxoSmithKline plc (ADR)(NYSE:GSK) with its Anoro Ellipta drug and Novartis AG (ADR) (NYSE:NVS) with NVS Utibron Neohaler. AstraZeneca has been focusing on respiratory treatments as one of its main therapy areas of focus.
AstraZeneca stock closed the latest trading session on Wednesday at $33.31 after tanking by 0.12 percent compared to the value of the stock during the previous close.