Nasopharyngitis, upper respiratory tract infection, headache, oral candidiasis; risk of asthma-related death.
How Supplied:
Dry powder inhaler—30 doses
LAST UPDATED:

10/30/2013

5月10日，美国食品药品管理局（FDA）批准Breo Ellipta用于包括慢性支气管炎和/或肺气肿在内的慢性阻塞性肺病（COPD）患者气流阻塞的长期维持治疗，该药物为糠酸氟替卡松和维兰特罗的吸入型复方药物粉末，可每日吸入一次。Breo Ellipta还被批准用于减少患者的慢性阻塞性肺病发作。
慢性阻塞性肺病是一种严重的肺疾病，可随时间的推移而恶化。症状有胸闷、久咳和过度痰液。根据美国国家心脏、肺和血液研究所提供的信息，吸烟是慢性阻塞性肺病的主要因素，而慢性阻塞性肺病在美国是第三大主要死亡原因。Breo Ellipta可通过减轻慢性阻塞性肺病患者肺部的炎症，以及松弛肺气道周围的肌肉来增加气流及减少疾病的发作。
FDA药品评价与研究中心药物评价II办公室的主任Curtis Rosebraugh医学博士说：“慢性阻塞性肺病是一种造成呼吸困难的严重疾病，新型的长期维持药物的应用为美国数百万遭受该病困扰的患者提供了一种新的治疗选择。”
Breo Ellipta中的糠酸氟替卡松是一种吸入型糖皮质激素，维兰特罗是一种长效β2肾上腺素受体激动剂（LABA）。该药物的安全性和有效性通过一项7700名慢性阻塞性肺病患者参与的临床试验进行了评价。用药组患者相比安慰剂组患者其肺部功能得到了改善，疾病发作次数减少。
Breo Ellipta在获批时其标签内容中有一项黑框警告，提示长效β2肾上腺素受体激动剂能增加哮喘有关的死亡风险。这款药物对哮喘患者的安全性和有效性还没得到确认，所以没被批准用于哮喘的治疗。
FDA在批准Breo Ellipta时附带一患者用药指南，内容包含该药物的使用说明和用药后的潜在风险信息。Breo Ellipta不能作为一种急救措施用于治疗突然的呼吸困难（急性支气管痉挛），也不建议用于18岁以下患者。
Breo Ellipta可能会引起严重的副作用，包括肺炎和骨折的风险增加。Breo Ellipta用药患者报道的最常见副作用有鼻腔炎症（鼻咽炎）、上呼吸道感染、头痛及口腔念珠菌病（鹅口疮）。
Breo Ellipta由葛兰素史克与总部位于旧金山的治疗先锋公司联合开发。

BREO® ELLIPTA™ now available in the U.S. for the treatment of COPD 
GlaxoSmithKline plc (LSE/NYSE: GSK) and Theravance, Inc. (NASDAQ: THRX) today announced that BREO ELLIPTA, a once-daily prescription medicine for chronic obstructive pulmonary disease (COPD), is now available to pharmacies throughout the U.S.
BREO ELLIPTA is a combination of the inhaled corticosteroid (ICS), fluticasone furoate “FF”, and the long-acting beta2-agonist (LABA), vilanterol “VI” (FF/VI 100/25 mcg). It is indicated for the long-term, once‐daily, maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema. BREO ELLIPTA is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations. BREO ELLIPTA is NOT indicated for the relief of acute bronchospasm or for the treatment of asthma.
“Patients and physicians have a new treatment option with BREO ELLIPTA, the first once-daily ICS/LABA for the maintenance treatment of COPD,” said Jorge Bartolome, Senior Vice President of GSK Respiratory Business Unit in the U.S. “This new option for healthcare providers to prescribe is good news for the millions of people in the U.S. affected by COPD.”
"Launching BREO ELLIPTA and making this important new medicine available to COPD patients is a significant milestone, which has been built upon many years of research and development,” said Rick E Winningham, Chief Executive Officer of Theravance. “We, like GSK, are proud to make the option of treatment with BREO ELLIPTA a reality for appropriate patients in the U.S.”
Under the terms of its 2002 LABA collaboration agreement with GSK, Theravance agreed to make a milestone payment of $30 million (USD) to GSK following the launch of BREO ELLIPTA in the U.S.
The FDA approved BREO ELLIPTA on May 10, 2013.
Full U.S. Prescribing Information, including BOXED WARNING and Medication Guide is available at us.gsk.com
For images and information about BREO ELLIPTA visit the eKit.
About COPD
Chronic obstructive pulmonary disease (COPD), which includes chronic bronchitis and emphysema, is characterised by obstruction to airflow that interferes with normal breathing. The National Heart, Lung and Blood Institute (NHLBI) estimates that as many as 27 million people in the US alone are affected by COPD, a number that is predicted to increase.
Many people with COPD periodically experience exacerbations, or flare-ups, a worsening of their COPD symptoms lasting a few days or longer, which may include an increase in shortness of breath, mucus production, cough, and a change in the color of sputum, fever, and fatigue. Exacerbations often require treatment with additional medications and sometimes hospitalization may be necessary.  Daily COPD management is important to help prevent future flare-ups in patients with a history of flare-ups.
Other FF/VI Regulatory Activity:
FF/VI 100/25 mcg was approved for the treatment of COPD by Health Canada in July 2013 under the trade name BREO ELLIPTA.  On September 20, 2013, the Japanese Ministry of Health, Labour and Welfare (MHLW) approved FF/VI 100/25 mcg and 200/25 mcg  for the treatment of bronchial asthma under the trade name RELVAR™ ELLIPTA™.  FF/VI is not indicated for the relief of acute bronchospasm or the treatment of asthma in the US or Canada.
In June 2012, a regulatory application for FF/VI was submitted in the European Union under the trade name RELVAR ELLIPTA for the treatment of patients with COPD and asthma, and gained a positive opinion from the Committee for Medicinal Products for Human Use in September 2013.  FF/VI is not approved or licensed in the European Union or anywhere outside of the US, Japan and Canada.
RELVAR, BREO and ELLIPTA are trademarks of the GlaxoSmithKline group of companies. The use of the brand name RELVAR is not approved by any regulatory authorities outside of Japan. 
Important Safety Information (ISI)
The following ISI is based on the Highlights section of the U.S. Prescribing Information for BREO ELLIPTA.  Please consult the full Prescribing Information for all the labeled safety information for BREO ELLIPTA.
Long-acting beta2-adrenergic agonists (LABAs), such as vilanterol, one of the active ingredients in BREO ELLIPTA, increase the risk of asthma-related death. A placebo-controlled trial with another LABA (salmeterol) showed an increase in asthma-related deaths in subjects receiving salmeterol. This finding with salmeterol is considered a class effect of all LABAs, including vilanterol.  The safety and efficacy of BREO ELLIPTA in patients with asthma have not been established.  BREO ELLIPTA is not indicated for the treatment of asthma.
BREO ELLIPTA is contraindicated in patients with severe hypersensitivity to milk proteins or who have demonstrated hypersensitivity to either fluticasone furoate, vilanterol, or any of the excipients.
BREO ELLIPTA should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of COPD, or as rescue therapy for the treatment of acute episodes of bronchospasm. Acute symptoms should be treated with an inhaled, short-acting beta2-agonist.
BREO ELLIPTA should not be used more often than recommended, at higher doses than recommended, or in conjunction with other medications containing LABAs, as an overdose may result.
Oropharyngeal candidiasis has occurred in patients treated with BREO ELLIPTA. Patients should rinse their mouth with water without swallowing after inhalation to help reduce this risk.
An increase in the incidence of pneumonia has been observed in subjects with COPD receiving the fluticasone furoate/vilanterol combination, including BREO ELLIPTA 100 mcg/25 mcg, in clinical trials. There was also an increased incidence of pneumonias resulting in hospitalization. In some incidences these pneumonia events were fatal.
Patients who use corticosteroids are at risk for potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex. A more serious or even fatal course of chickenpox or measles may occur in susceptible patients.
Particular care is needed for patients who have been transferred from systemically active corticosteroids to inhaled corticosteroids because deaths due to adrenal insufficiency have occurred in patients with asthma during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids.
Hypercorticism and adrenal suppression may occur with very high dosages or at the regular dosage of inhaled corticosteroids in susceptible individuals.
Caution should be exercised when considering the coadministration of BREO ELLIPTA with long‐ erm ketoconazole and other known strong CYP3A4 inhibitors because increased systemic corticosteroid and cardiovascular adverse effects may occur.
As with other inhaled medicines, BREO ELLIPTA can produce paradoxical bronchospasm which may be life-threatening. Vilanterol, the LABA in BREO ELLIPTA, can produce clinically significant cardiovascular effects in some patients as measured by increases in pulse rate, systolic or diastolic blood pressure, and also cardiac arrhythmias. Decreases in bone mineral density have been observed with long-term administration of products containing inhaled corticosteroids, as have glaucoma, increased intraocular pressure, and cataracts.
BREO ELLIPTA should be used with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, ketoacidosis, and in patients who are unusually responsive to sympathomimetic amines.
Beta-adrenergic agonist medicines may produce significant hypokalemia in some patients.  Beta-adrenergic agonist medicines may produce transient hyperglycemia in some patients.
The most common adverse reactions (≥3% and more common than in placebo) reported in two 6-month clinical trials with BREO ELLIPTA (and placebo) were nasopharyngitis, 9% (8%); upper respiratory tract infection, 7% (3%); headache, 7% (5%); and oral candidiasis, 5% (2%).  In addition to the events reported in the 6-month studies, adverse reactions occurring in ≥3% of the subjects treated with BREO ELLIPTA in two 1-year studies included COPD, back pain, pneumonia, bronchitis, sinusitis, cough, oropharyngeal pain, arthralgia, hypertension, influenza, pharyngitis, diarrhea, peripheral edema, and pyrexia.