葛兰素史克（GSK）与Theravance公司6月30日宣布，已向FDA提交了新复方药Breo Ellipta（2种剂量，100/25mcg和200/25mcg）的补充新药申请（sNDA），寻求批准作为每日一次的吸入性疗法，用于12岁及以上哮喘（asthma）患者的治疗。该药sNDA的提交，是基于Breo Ellipta用于哮喘治疗的广泛临床开发项目的数据，该项目包括48个临床药理学研究和23个临床研究。
BREO ELLIPTA是新复方药物FF/VI（fluticasone furoate /vilanterol，100/25 mcg）的商品名，该药为每日一次的吸入型糖皮质激素糠酸氟替卡松(FF)和长效β2受体激动剂维兰特罗(VI)的复方药物，开发用于慢性阻塞性肺病（COPD）和哮喘（asthma）的治疗。
BREO ELLIPTA于2013年5月获FDA批准，作为每日一次的吸入性疗法，用于慢性阻塞性肺病（COPD）患者的长期维持治疗，包括慢性支气管炎和/或肺气肿。此外，该药还适用于既往有COPD病情加重(COPD exacerbation)病史患者的COPD病情加重的减少。
英文原文：GSK and Theravance announce submission to US regulatory authorities for fluticasone furoate/vilanterol in asthma
GlaxoSmithKline plc (LSE/NYSE: GSK) and Theravance, Inc. (NASDAQ: THRX) today announced the submission of a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) for a fixed dose combination of the inhaled corticosteroid, fluticasone furoate and the long-acting beta2 agonist, vilanterol (FF/VI) as a once-daily treatment for asthma in patients aged 12 years and older, with the brand name of Breo® Ellipta®.
The sNDA is seeking approval for two dose regimens, 100/25mcg and 200/25mcg, administered once daily using the Ellipta dry powder inhaler.
Today’s filing is based upon data generated from the comprehensive clinical development programme for FF/VI in asthma. The clinical development programme comprised 48 clinical pharmacology studies in 1,328 subjects and 23 clinical studies in 12,051 patients with asthma, including the Phase III efficacy and safety study of FF/VI reported in December 2013.
about asthma
Asthma is a chronic lung disease that inflames and narrows the airways, causing recurring periods of wheezing, chest tightness, shortness of breath and coughing which often occurs at night or early in the morning.
Despite medical advances, more than half of patients continue to experience poor control and significant symptoms.2The causes of asthma are not completely understood but likely involve an interaction between a person’s genetic make-up and the environment.
Key risk factors are inhaled substances that provoke allergic reactions or irritate the airways. These include allergens such as dust mites and pets.
about Breo Ellipta in the US
FF/VI 100/25mcg was approved by the US Food and Drug Administration under the brand name Breo Ellipta in May 2013 as a prescription medication for the long-term, once-daily, maintenance treatment of airflow obstruction and for reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Breo Ellipta is not indicated for the relief of acute bronchospasm or the treatment of asthma in the US.
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