GSK COPD新复方药Anoro获欧盟批准


2014年5月9日讯 /生物谷BIOON/ --葛兰素史克(GSK)5月8日宣布,新复方药Anoro Ellipta(umeclidinium/vilanterol,UMEC/VI,55mcg/22mcg)获欧盟委员会(EC)批准,作为每日一次的维持治疗用支气管扩张剂,用于缓解慢性阻塞性肺病(COPD)患者的症状。GSK预计将于2014年第二至第三季度在欧洲推出Anoro Ellipta。

Anoro Ellipta的获批,是基于UMEC/VI 关键性III期项目的数据,该项目包括7项III期临床试验,涉及近6000例COPD患者。

Anoro Ellipta结合了2种长效支气管扩张剂,是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,通过新型干粉吸入器Ellipta给药。

UMEC/VI是葛兰素史克的一个独特产品,于2013年12月获FDA批准以商品名Anoro Ellipta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。(生物谷

英文原文:Anoro? (umeclidinium/vilanterol) gains marketing authorisation in Europe for the treatment of COPD

Issued: 8 May 2014, London UK and South San Francisco, CA, USA – LSE announcement

GlaxoSmithKline plc (LSE/NYSE: GSK) and Theravance, Inc. (NASDAQ: THRX) today announced that the European Commission has granted marketing authorisation for Anoro? (umeclidinium/vilanterol) as a once-daily, maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

Anoro is a once-daily combination treatment comprising two bronchodilators, umeclidinium (UMEC), a long-acting muscarinic antagonist (LAMA), and vilanterol (VI), a long-acting beta2 agonist (LABA), in a single inhaler, the Ellipta?. The licensed strength in Europe is UMEC/VI 55mcg / 22mcg.

Darrell Baker, SVP & Head, GSK Global Respiratory Franchise, said, “There are many people across Europe living with COPD who experience a variety of symptoms and for whom the disease represents a significant burden. GSK is committed to developing a range of new therapeutic options that provide physicians with treatment choices when considering individual patient needs. We are delighted by today’s marketing authorisation for Anoro Ellipta which provides a new alternative for COPD patients for whom dual bronchodilator treatment in a single inhaler may be appropriate.”

Under the terms of the 2002 LABA collaboration agreement, Theravance is obligated to make a milestone payment to GSK of $15 million (USD) following marketing authorisation for UMEC/VI by the European Commission.  A further $15 million (USD) payment to GSK will follow the launch of UMEC/VI in Europe.

The first launch is expected to take place in Europe in Q2-3 2014 with additional launches to follow thereafter.

The EMA assessment of UMEC/VI included a review of eight phase III clinical trials which included over 6,000 COPD patients. Within this, 1,296 patients received the recommended dose of UMEC/VI 55/22mcg once-daily.











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