COPD Triple-combination Therapy Approved in China, AstraZeneca Announces

COPD Triple-combination Therapy Approved in China, AstraZeneca Announces
AstraZeneca’s triple-combination therapy for people with chronic obstructive pulmonary disease (COPD) has been approved in China as a maintenance treatment. The therapy comprises three compounds: the corticosteroid budesonide, and two long-acting bronchodilators — glycopyrronium, a muscarinic antagonist, and formoterol fumarate, a β2-agonist. This combo treatment is known as PT010 outside of China, and as Breztri Aerosphere in Japan. It uses AstraZeneca’s Aerosphere Delivery Technology, a delivery system based on a special aerosol formulation (inhalation aerosol). “With this approval, we are now able to provide a powerful new triple-combination therapy to patients for whom new treatments are critically needed. Our triple-combination therapy is administered in a pressurised metered-dose inhaler, an important device option for clinicians and patients in China,” Mene Pangalos, executive vice president of biopharmaceuticals research and development at AstraZeneca, said in a press release. According to Pangalos, COPD "affects almost 100 million people in China, and is a leading cause of morbidity and mortality." The new approval was based on the results of a Phase 3 clinical trial called KRONOS (NCT02497001), which compared the triple combo with the dual-combination therapies PT009 — containing formoterol fumarate and budesonide — and Bevespi Aerosphere, which contains formoterol fumarate and glycopyrronium. Patients participating in the 24-week KRONOS trial had moderate-to-very-severe COPD. The results showed that patients with COPD who received the triple combo had improved respiratory function and a 52% reduction in the frequency of moderate or severe exacerbations compared with patients receiving only the dual-combination therapies.
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