GSK's Trelegy Ellipta, the World’s First Once-Daily Single-Inhaler Triple Therapy for COPD, Approved in China

Source:PharmaCube Info

Original: Vernacular Chinese

Chronic Obstructive Pulmonary Disease (COPD), commonly known as chronic bronchitis and emphysema, is a chronic inflammatory airway disease caused by inhalation of tobacco smoke, occupational dusts, or polluted air. Clinically, it is primarily characterized by progressively worsening dyspnea, with or without cough and sputum production. Pulmonary function tests demonstrate obstructive ventilatory impairment. Disease progression can readily lead to respiratory failure and cor pulmonale.

On November 6, Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol inhalation powder), a triple therapy for chronic obstructive pulmonary disease (COPD) developed by GSK, was approved for marketing by the National Medical Products Administration.

Trelegy Ellipta was first approved by the FDA for marketing on September 18, 2017, for the maintenance treatment of chronic obstructive pulmonary disease (COPD). It is the world’s first once-daily triple therapy, with global sales reaching £156 million in 2018. GSK filed for market approval of this product in China on June 27, 2018, and it was included in the priority review program on September 11, 2018.

This triple therapy consists of fluticasone furoate, umeclidinium, and vilanterol. Fluticasone furoate is a synthetic trifluorinated corticosteroid with potent anti-inflammatory activity; umeclidinium is a long-acting muscarinic antagonist; and vilanterol is a long-acting β2-adrenergic agonist that provides 24-hour sustained bronchodilation.

A Phase III IMPACT study involving 10,355 patients with COPD demonstrated that Trelegy Ellipta was superior to the dual therapies Relvar/Breo Ellipta (Wanruishu) and Anoro Ellipta (Oulexin) in reducing exacerbations among high-risk COPD patients with a history of exacerbations, achieving the primary endpoint with a 15% and 25% reduction in the annual rate of moderate-to-severe exacerbations during treatment at Week 52, respectively.

Source: PharmaCube NextPharma

GSK is a leading enterprise in respiratory disease medications and has launched multiple new drugs for COPD in recent years. On March 12, 2018, GSK’s dual bronchodilator Anoro Ellipta (umeclidinium/vilanterol inhalation powder) was approved in China for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). On July 31, 2018, GSK’s dual therapy Breo Ellipta (fluticasone furoate/vilanterol inhalation powder) was also approved in China for the treatment of asthma and COPD.