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GSK和Theravance宣布COPD新复方药Anoro Ellipta 3项III期取得积极数据

发布时间:2014年03月15日 18:10:33

葛兰素史克(GSK)和合作伙伴Theravance制药3月14日联合宣布,COPD新复方药Anoro Ellipta 3项III期研究均取得积极数据。其中2项研究(Study 114930和Study 114951)比较了Anoro Ellipta和该公司已上市复方药Advair Diskus(FSC,250/50mcg)的疗效和安全性。另一项研究(Study 116134)比较了Anoro Ellipta和Seretide Diskus(FSC,500/50mcg)的疗效和安全性。

 

数据表明,3项研究中,Anoro Ellipta均显著的改善了慢性阻塞性肺病(COPD)患者的肺功能。

 

Anoro Ellipta是COPD新复方药物UMEC/VI(umeclidinium/vilanterol,62.5/25 mcg)的商品名,该药结合了2种长效支气管扩张剂,为长效毒蕈碱受体拮抗剂(LAMA)UMEC(umeclidinium)和长效β2受体激动剂(LABA)维兰特罗(VI,vilanterol)的复方药物,通过新型干粉吸入器Ellipta给药。

 

Anoro Ellipta是葛兰素史克的一个独特产品,于2013年12月获FDA批准上市,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肺气肿。Anoro Ellipta不适用于急性支气管痉挛(acute bronchospasm)的缓解或哮喘(asthma)的治疗。

 

同时,Anoro Ellipta是FDA批准的首个LAMA/LABA组合药物,该药是葛兰素史克老药Advair的继任者,后者在美国和欧盟已失去专利保护。Advair是葛兰素史克最畅销的药物,销售额约占该公司总销售额的近五分之一。

 

此前,汤姆森路透分析师平均估计,Anoro Ellipta在2018年的销售额将超过20亿美元。

 

GlaxoSmithKline Studies on Lung Disease Drug Show Positive Results

 

LONDON--U.K. pharmaceuticals giant GlaxoSmithKline PLC (GSK.LN) Friday said three late-stage studies into a lung disease drug it developed with San Francisco-based Theravance Inc.(THRX) produced positive results.

 

Anoro Ellipta is a treatment for chronic obstructive pulmonary disease, or COPD, a condition typically brought on by smoking which affects nearly 27 million people in the U.S. according to the National Heart, Lung and Blood Institute.

 

The "phase three" studies showed patients treated with the drug showed significant improvement in lung function compared with people administered with different treatments, GSK said.

 

The studies compared Anoro Ellipta to existing Glaxo treatment Advair, marketed in Europe as Seretide. Anoro Ellipta is a new treatment from Glaxo for COPD and is designed as a successor product to Advair, which has lost patent protection in the U.S. and Europe.

 

Advair is Glaxo's best-selling drug, responsible for just under a fifth of its total sales.

 

"We are pleased to communicate these data comparing the effect of these treatments on the lung function of patients with COPD who do not have a history of exacerbations," said Darrell Baker, senior vice president for medicines development at GSK.

 

"These findings add to the existing body of evidence and our understanding of the efficacy and safety of UMEC/VI," he added. UMEC/VI is the combination of two drugs found in Anoro Ellipta.

 

 

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