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分类 » 药理学动态
GSK在美国推出COPD新复方药BREO ELLIPTA
2013-11-03    

葛兰素史克(GSK)与Theravance公司10月30日宣布,在美国推出新复方药物BREO ELLIPTA,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,但不适用于缓解急性支气管痉挛或哮喘的治疗。

BREO ELLIPTA是实验性COPD新复方药物FF/VI(fluticasone furoate /vilanterol,100/25 mcg)的拟用商品名,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,旨在开发用于慢性阻塞性肺病(COPD)和哮喘的治疗。

根据2002年所达成的LABA合作协议,在美国推出BREO ELLIPTA,Theravance将有资格获得3000万美元的里程碑款项。

BREO ELLIPTA于2013年5月10日获FDA批准。(生物谷Bioon.com)

英文原文:BREO(R) ELLIPTA(TM) Now Available in the U.S. for the Treatment of COPD

RESEARCH TRIANGLE PARK, NC and SOUTH SAN FRANCISCO, CA -- (Marketwired) -- 10/30/13 -- GlaxoSmithKline plc (LSE: GSK) (NYSE: GSK) and Theravance, Inc. (NASDAQ: THRX) today announced that BREO ELLIPTA, a once-daily prescription medicine for chronic obstructive pulmonary disease (COPD), is now available to pharmacies throughout the U.S.

BREO ELLIPTA is a combination of the inhaled corticosteroid (ICS), fluticasone furoate "FF", and the long-acting beta2-agonist (LABA), vilanterol "VI" (FF/VI 100/25 mcg). It is indicated for the long-term, once‐daily, maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema. BREO ELLIPTA is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations. BREO ELLIPTA is NOT indicated for the relief of acute bronchospasm or for the treatment of asthma.

"Patients and physicians have a new treatment option with BREO ELLIPTA, the first once-daily ICS/LABA for the maintenance treatment of COPD," said Jorge Bartolome, Senior Vice President of GSK Respiratory Business Unit in the U.S. "This new option for healthcare providers to prescribe is good news for the millions of people in the U.S. affected by COPD."

"Launching BREO ELLIPTA and making this important new medicine available to COPD patients is a significant milestone, which has been built upon many years of research and development," said Rick E Winningham, Chief Executive Officer of Theravance. "We, like GSK, are proud to make the option of treatment with BREO ELLIPTA a reality for appropriate patients in the U.S."

Under the terms of its 2002 LABA collaboration agreement with GSK, Theravance agreed to make a milestone payment of $30 million (USD) to GSK following the launch of BREO ELLIPTA in the U.S.

The FDA approved BREO ELLIPTA on May 10, 2013.

转载自:生物谷

链接:

http://www.bioon.com/industry/drug/585369.shtml

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