GSK新复方药Anoro Ellipta获FDA批准

葛兰素史克（GSK）和Theravance制药上周联合宣布，新复方药Anoro Ellipta已获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。

GSK计划于2014年第一季度在美国推出Anoro Ellipta。

Anoro Ellipta是实验性COPD新复方药物UMEC/VI（umeclidinium/vilanterol，62.5/25 mcg）的拟用商品名，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，是获FDA批准的首个LAMA/LABA组合药物，将与勃林格殷格翰（Boehringer Ingelheim）和辉瑞（Pfizer）的长效毒蕈碱受体拮抗剂（LAMA）思力华（Spiriva）竞争，Spiriva也被称为噻托溴铵，是市场上唯一销售的LAMA。

GSK于2012年12月向FDA提交了Anoro Ellipta的新药申请（NDA），同时，该药于今年9月获得了FDA肺过敏药物顾问委员会（PADAC）建议批准的积极意见。

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。

此外，GSK与Theravance的一款COPD新复方药物Breo（美国以外的国家称为Relvar）分别于今年5月和11月获FDA和欧盟委员会（EC）批准，该药为每日1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，分析师预计，该药在2018年的销售将达到19亿美元。

英文原文：ANORO(TM) ELLIPTA(TM) Approved as First Once-Daily Dual Bronchodilator for the Treatment of COPD in the US

LONDON, UK and SOUTH SAN FRANCISCO, CA--(Marketwired - Dec 18, 2013) - GlaxoSmithKline plc (LSE: GSK) (NYSE: GSK) and Theravance, Inc. (NASDAQ: THRX) today announced that the US Food and Drug Administration (FDA) has approved ANORO™ ELLIPTA™ as a combination anticholinergic/long-acting beta2-adrenergic agonist (LABA) indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Anoro Ellipta is not indicated for the relief of acute bronchospasm or for the treatment of asthma.

Anoro Ellipta (umeclidinium and vilanterol inhalation powder) is the first once-daily product approved in the US that combines two long-acting bronchodilators in a single inhaler for the maintenance treatment of COPD. The FDA-approved strength is umeclidinium/vilanterol 62.5 mcg/25 mcg.

Darrell Baker, SVP & Head, GSK Global Respiratory Franchise, said: "We believe Anoro Ellipta will be an important treatment option for appropriate patients with COPD. It is the first combination product approved in the US that delivers two once-daily bronchodilators in a single inhaler. This approval is a significant achievement for GSK."

"We are very pleased that Anoro Ellipta has become the first once-daily dual bronchodilator approved in the US for the treatment of COPD," said Rick E Winningham, Chief Executive Officer of Theravance. "This is a significant milestone for Theravance and GSK and is testament to our ongoing partnership and shared commitment to the development of respiratory medicines."

Following this approval by the FDA, it is anticipated that launch activities in the US will commence during the first quarter of 2014. Under the terms of the 2002 LABA collaboration agreement, Theravance is obligated to make a milestone payment of $30 million (USD) to GSK following FDA approval of Anoro Ellipta. A further $30 million (USD) payment to GSK will follow the launch of Anoro Ellipta in the US.

The phase III pivotal programme for Anoro Ellipta included seven clinical studies with almost 6,000 patients with COPD.

About COPD
Chronic obstructive pulmonary disease (COPD) is a disease of the lungs that includes chronic bronchitis, emphysema or both. COPD is characterised by obstruction to airflow that interferes with normal breathing. The National Heart, Lung and Blood Institute (NHLBI) estimates that nearly 27 million people in the US alone are affected by COPD.(i)

According to the NHLBI, long-term exposure to lung irritants that damage the lungs and the airways are usually the cause of COPD. In the United States, the most common irritant that causes COPD is cigarette smoke. Breathing in second hand smoke, air pollution, chemical fumes or dust from the environment or workplace also can contribute to COPD. Most people who have COPD are at least 40 years old when symptoms begin.

About Anoro Ellipta
Anoro Ellipta is the first once-daily anticholinergic/LABA combination product approved in the US for the long-term once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Anoro Ellipta is not indicated for the relief of acute bronchospasm or for the treatment of asthma. Anoro contains 62.5 mcg umeclidinium, an anticholinergic, and 25 mcg vilanterol, a LABA, in a single inhaler, the Ellipta.

Full US Prescribing Information, including BOXED WARNING and Medication Guide will be available soon at: us.gsk.com. Prior to the label being posted online, a copy of the label may be requested from one of the GSK Media or Investor Relations contacts listed in the "GSK Inquiries" section at the end of this document.