FDA批准氟替美维吸入粉雾剂(Trelegy Ellipta)用于治疗哮喘

On September 9, 2020, GlaxoSmithKline plc and Innoviva, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved a new indication for flutimavir inhalation powder (Trelegy Ellipta) for the treatment of asthma in patients 18 years of age and older, adding a new use to its existing chronic obstructive pulmonary disease indication. Flutimavir inhalation powder (Trelegy Ellipta) is not indicated for the relief of acute bronchospasm.

The FDA-approved specifications for chronic obstructive pulmonary disease and asthma are fluticasone furoate/umeclidinium bromide/vilanterol 100/62.5/25mcg. There is also a strength only for asthma, namely fluticasone furoate/umeclidinium bromide/vilanterol 200/62.5/25mcg.

This approval means that flutimavir inhalation powder becomes the first single-inhaler triple therapy approved for the maintenance treatment of asthma and chronic obstructive pulmonary disease, and is the only single-inhaler triple therapy in the United States that is convenient for once-daily inhalation and is available to patients. Today’s announcement marks GSK’s sixth major drug approval in 2020, covering areas of high unmet medical need such as cancer, HIV, respiratory and chronic kidney disease.

Dr. Hal Barron, chief scientific officer and president of research and development at GSK, said: "Millions of asthma patients in the United States rely on multiple inhalers to control their condition and manage their symptoms. Today's approval is an important advancement for these patients because it allows them to benefit from triple therapy once daily with one inhaler."

Flutimavir inhalation powder (Trelegy) The approval of Ellipta for the maintenance treatment of asthma in patients 18 years of age and older introduces a new paradigm for the management of the approximately 30% of adult asthma patients who continue to experience symptoms despite adherence to inhaled corticosteroid/long-acting beta2 agonist (ICS/LABA) combination therapy.

Tonya Winders, President of the Global Allergy and Airway Patient Platform (GAAPP), commented: "Nearly 20 million adults in the United States live with asthma, and we know that many of them continue to live with symptoms and adjust their lives around them despite taking medications as prescribed by their doctors. We welcome this news and, for the right people, patients, Trelegy will now be available as a new treatment option. "

Today's approval is based on a supplemental new drug application that includes data from the CAPTAIN study, which showed that flutimavir inhaled powder (Trelegy) compared with FF/VI in patients with poorly controlled ICS/LABA. Ellipta's additional bronchodilation in an easy-to-use inhaler has shown significant improvements in lung function in a once-daily dose. The CAPTAIN findings, presented this week at the European Respiratory Society (ERS) Congress, reinforce the potential of once-daily single-inhaler triple therapy in asthma management.

Innoviva CEO Pavel Raifeld said: "In 2017, flutimavir inhalation powder spray (Trelegy Ellipta was approved in the U.S. as the first once-daily, single-inhaler triple therapy for the treatment of chronic obstructive pulmonary disease, and it remains the market leader with continued strong growth. Today's approval in asthma is another successful outcome of our long-term partnership with GSK and demonstrates our commitment to making innovative medicines available to patients with respiratory diseases."

About Asthma

Asthma is a chronic lung disease that causes inflammation and narrowing of the airways. Asthma affects 358 million people worldwide. Despite ongoing medical advances, more than half of patients continue to experience significant symptoms that are poorly controlled and severely impact daily life.

The cause of asthma is not fully understood, but may involve an interaction between an individual's genetic makeup and the environment. Key risk factors are inhaled substances that trigger allergic reactions or irritate the airways.

About the situation of flutimavir inhalation powder (Trelegy Ellipta) in the United States

Flutimavir inhalation powder (Trelegy Ellipta) is a combination of three molecules in a single inhaler that only needs to be inhaled once daily. It contains the inhaled corticosteroid fluticasone furoate, the long-acting muscarinic antagonist umeclidinium bromide and the long-acting beta2-adrenergic agonist vilanterol, and is delivered via GSK's Elixir dry powder inhaler.