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。
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.