FDA批准氟替美维吸入粉雾剂(Trelegy Ellipta)用于治疗慢性阻塞性肺疾病

On September 18, 2017, GlaxoSmithKline plc and Innoviva, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the once-daily, single-inhaler triple therapy fluoride TrelegyEllipta, marketed under the brand name TrelegyEllipta, is indicated for the long-term, once-daily maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), including patients with chronic bronchitis and/or emphysema.

These patients are receiving a fixed-dose combination of fluticasone furoate and vilanterol to improve airflow obstruction and reduce exacerbations and require additional airflow obstruction treatment; or for patients already receiving umeclidinium bromide and a fixed-dose combination of fluticasone furoate and vilanterol. Flutimavir inhalation powder is not indicated for the relief of acute bronchospasm or the treatment of asthma.

Flutimavir inhalation powder (Trelegy Ellipta) is a combination of an inhaled corticosteroid (ICS), a long-acting muscarinic antagonist (LAMA) and a long-acting beta2-adrenergic agonist (LABA), administered once daily through GSK's Yili Chang dry powder inhaler. It is the first once-daily product approved in the U.S. to combine three active molecules in a single inhaler for the maintenance treatment of appropriate COPD patients. The FDA approved specification is FF/UMEC/VI100/62.5/25mcg.

Eric Dube, senior vice president and head of GSK's global respiratory business, said: "COPD is a progressive disease that worsens over time and poses a significant burden to patients and the healthcare system. The approval of flutimavir inhalation powder and the addition of once-daily single inhaler triple therapy to our respiratory portfolio is an important milestone for GSK A monument that builds on our long tradition in this field. "

On September 15, 2017, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending the approval of FF/UMEC/VI as maintenance therapy for adult patients with moderate to severe COPD who are poorly controlled with the combination of inhaled corticosteroids and long-acting beta2-agonists. A positive opinion is one of the final steps before the European Commission grants marketing authorization. The proposed trade name of flutimavir inhalation powder remains pending regulatory approval in Europe. FF/UMEC/VI is not licensed as a single inhaler triple therapy anywhere outside the United States.

About Chronic Obstructive Pulmonary Disease (COPD)

COPD is a common but serious lung disease believed to affect 384 million people worldwide.

For people with COPD, the inability to breathe properly can consume their daily lives and make simple activities, like walking up stairs, a daily struggle.

Prolonged 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 dusts in the environment or workplace can all cause COPD. Most people with COPD are at least 40 years old when symptoms begin.

Every COPD patient is different, with different needs, different challenges, and different goals. Understanding this and providing support to meet these needs is fundamental to GSK's work.

About Flutimavir Inhalation Powder (Trelegy Ellipta)

Flutimavir Inhalation Powder is the first once-daily single-inhaler triple therapy approved in the United States for the long-term, once-daily maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), including those with chronic bronchitis and/or emphysema. These patients are receiving a fixed-dose combination of fluticasone furoate and vilanterol to improve airflow obstruction and reduce exacerbations and require additional airflow obstruction treatment; or for patients already receiving umeclidinium bromide and a fixed-dose combination of fluticasone furoate and vilanterol. Flutimavir inhalation powder is not indicated for the relief of acute bronchospasm or the treatment of asthma.

Important safety information for flutimavir inhalation powder (Trelegy Ellipta)

Long-acting beta2-adrenergic agonists (LABA), such as vilanterol, increase the risk of asthma-related death. A placebo-controlled trial using another LABA (salmeterol) showed an increase in asthma-related deaths. This finding with salmeterol is considered a class effect for all LABAs. The safety and effectiveness of terflutimevir inhalation powder in patients with asthma have not been established. Teflutimevir inhalation powder is not suitable for the treatment of asthma.

Flutimavir Inhalation Powder is contraindicated in patients with a history of severe allergy to milk protein or any component of Teflutimevir Inhalation Powder.

Patients who are experiencing an acute exacerbation of COPD should not initiate flutemevir inhalation powder and should not use flutemevir inhalation powder to treat acute symptoms.

Due to the risk of overdose, flutemevir inhalation powder should not be used in combination with other LABA-containing medications.

Oropharyngeal Candida albicans infection has occurred in patients treated with fluticasone furoate, one of the components of flutemevir inhalation powder. Monitor patients regularly. Advise patients to rinse their mouth with water after inhalation (do not swallow) to help reduce risk.

COPD patients using flutimavir inhalation powder are at increased risk of pneumonia. Monitor patients for signs and symptoms of pneumonia.

Patients taking corticosteroids are at risk for potentially worsening of an infection (e.g., existing tuberculosis; fungal, bacterial, viral, or parasitic infection; or ocular herpes simplex). Use flutimavir inhalation powder with caution in patients with these infections. Susceptible patients may develop a more severe or fatal course of chickenpox or measles.

There is a risk of impaired adrenal function when switching from systemic corticosteroids. If switching to flutimavir inhalation powder, patients should be slowly tapered from systemic corticosteroids.

Hypercortisolism and adrenal suppression may occur in susceptible individuals using very high doses or conventional doses of flutimavir inhalation powder. If such changes occur, consider appropriate treatment.

If paradoxical bronchospasm occurs, flutimevir inhalation powder should be discontinued and alternative therapy should be initiated.

Use flutimevir inhalation powder with caution in patients with cardiovascular disease due to beta-adrenergic stimulating effects.

After prescribing flutimavir inhalation powder, assess patients initially and periodically thereafter for loss of bone mineral density.

Patients taking flutimavir inhalation powder need to be closely monitored for glaucoma and cataracts. Narrow-angle glaucoma may worsen. Use with caution in patients with narrow-angle glaucoma and instruct patients to contact their healthcare provider immediately if symptoms occur.

Exacerbation of urinary retention may occur in patients taking flutimavir inhalation powder. Use with caution in patients with prostatic hyperplasia or bladder neck obstruction and instruct patients to contact their healthcare provider immediately if symptoms occur.

Use flutimevir inhalation powder with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis.

Be alert to hypokalemia and hyperglycemia in patients using flutimavir inhalation powder.

The most common adverse reactions (incidence ≥1%) reported with flutimavir inhalation powder include headache, back pain, dysgeusia, diarrhea, cough, oropharyngeal pain, and gastroenteritis.