每日一次用药氟替美维吸入粉雾剂(Trelegy Ellipta)在美国获得慢性阻塞性肺病的扩大适应症

On April 24, 2018, GlaxoSmithKline plc and Innoviva, Inc. jointly announced that the U.S. Food and Drug Administration (FDA) has approved the expanded indications for flutimavir inhalation powder (Trelegy Ellipta). This means that U.S. doctors can now use the drug to treat a broader group of patients with chronic obstructive pulmonary disease (COPD), including those who have airflow limitation or experience acute exacerbations of respiratory symptoms.

New indications for flutimavir inhalation powder (Trelegy Ellipta)

It is suitable for long-term, once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (including chronic bronchitis and/or emphysema). The drug is also indicated for patients with chronic obstructive pulmonary disease who have a history of exacerbations to reduce their risk of exacerbations. It should be noted that this drug is not indicated for the relief of acute bronchospasm, nor is it indicated for the treatment of asthma.

Dr. Hal Barron, chief scientific officer and president of R&D at GlaxoSmithKline, said: “Since the first approval of flutimavir inhalation powder last September, we have analyzed data from the IMPACT study and discovered the additional benefits of this important medicine for patients with COPD. We are pleased that the robust data from the IMPACT study made the expanded indication announced today possible and that the FDA has acted so quickly. We will continue to analyze data from the IMPACT trial and our ongoing flutimavir inhalation powder study to further demonstrate the value of this important medicine to patients.

This approval is based on a supplemental New Drug Application (sNDA) supported by the landmark IMPACT study. Data show that flutemevir inhalation powder mist is superior to the inhaled corticosteroid/long-acting β2-adrenoceptor agonist (ICS/LABA) combination drug Venresu (FF/VI) and the long-acting muscarinic antagonist/long-acting β2-adrenoceptor agonist (LAMA/LABA) combination drug Olexin (UMEC/VI) on multiple clinically important endpoints, including reducing acute exacerbations, improving lung function, and improving health-related quality of life.

Dr. Ted Witek, senior vice president and chief scientific officer of Innoviva, added: Up to half of COPD patients receiving maintenance therapy have experienced at least one exacerbation in the past 12 months. Therefore, it is important to have an indication that reflects the role flutimavir inhalation powder can play in reducing this risk. We welcome this regulatory update, which will enable physicians to offer the benefits of once-daily single-inhaler triple therapy to appropriate patients with COPD.

About Flutimavir Inhalation Powder Nebula (TrelegyEllipta)

Flutimavir Inhalation Powder Nebula (TrelegyEllipta) was initially approved in the United States in September 2017 for long-term, once-daily maintenance treatment. The applicable population is patients who are receiving Varasu and need additional bronchodilation, or patients who are receiving Varasu and UMEC simultaneously. A Class II change designed to support expanded labeling in Europe was submitted to the European Medicines Agency (EMA) in February 2018 and is currently under review.

Flutimavir inhalation powder (Trelegy Ellipta) is the first chronic obstructive pulmonary disease treatment drug that combines three molecules in a single inhaler and requires only one inhalation per day. It contains the inhaled corticosteroid fluticasone, the long-acting muscarinic antagonist umeclidinium bromide and the long-acting beta-2 adrenoceptor agonist vilanterol, and is administered via GlaxoSmithKline's dry powder inhaler, which is used across GlaxoSmithKline's entire portfolio of new inhaled COPD medicines.

About COPD

Chronic obstructive pulmonary disease is a progressive lung disease believed to affect approximately 384 million people worldwide.

For people with COPD, the inability to breathe properly can drain their energy from daily life and make simple activities like walking up the stairs a daily struggle. People with COPD suffer from symptoms of dyspnea, and many are at significant risk of exacerbations. Managing these aspects of the disease is a major driver in physicians' choice of treatment options.

Chronic exposure to inhaled irritants that damage the lungs and airways is often the cause of COPD. Cigarette smoke, second-hand smoke inhalation, air pollution, chemical fumes or dust in the environment or workplace can all contribute to COPD. Most people with COPD are at least 40 years old when symptoms begin.