CHMP建议批准GSK COPD新复方药Anoro


2014年2月21日讯 /生物谷BIOON/ --葛兰素史克(GSK)和Theravance制药2月20日联合宣布,新复方药Anoro(umeclidinium/vilanterol,UMEC/VI)获得了欧洲药品管理局(EMA)人用医药产品委员会(CHMP)的积极意见。CHMP建议批准Anoro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。欧盟委员会(EC)将于2014年第二季度做出最终审查决定。

CHMP的积极意见,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(LABA)维兰特罗(VI,vilanterol)的复方药物,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。

Anoro Ellipta是FDA批准的首个LAMA/LABA组合药物。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。(生物谷

英文原文:GSK Anoro? (umeclidinium / vilanterol) receives positive opinion from the CHMP in Europe for the treatment of COPD

Issued: Thursday 20 February 2014, London UK – LSE Announcement

GlaxoSmithKline plc (LSE/NYSE: GSK) and Theravance, Inc. (NASDAQ: THRX) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorisation for umeclidinium/vilanterol (UMEC/VI) under the proposed brand name Anoro? as a once-daily, maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

Anoro is a combination of UMEC, a long-acting muscarinic antagonist (LAMA) and VI, a long-acting beta2 agonist (LABA) in a single inhaler, the Ellipta?. The proposed strength is UMEC/VI 55mcg / 22 mcg.

Patrick Vallance, GSK’s President of Pharmaceuticals R&D, said, “COPD affects millions of people across Europe and GSK is committed to developing new therapeutic options that could help these patients. Today’s positive opinion is a step towards us making this important new medicine available. We are looking forward to the final decision of the European Commission in the near future.”

“We are pleased with the positive opinion which brings UMEC/VI closer to approval in Europe,” said Rick E Winningham, Chief Executive Officer of Theravance. “This is an important milestone and reflects the ongoing efforts of the collaboration between Theravance and GSK to research and develop new respiratory medicines that meet patient needs.”

A CHMP positive opinion is one of the final steps before marketing authorisation is granted by the European Commission. A final decision by the European Commission is anticipated during the second quarter of 2014.

The phase III pivotal programme for UMEC/VI included seven clinical studies with almost 6,000 patients with COPD.

In December 2013, Anoro? Ellipta? 62.5mcg / 25mcg was approved for use in appropriate patients with COPD by both the US Food and Drug Administration and Health Canada. In Europe, the UMEC/VI strength of 55mcg / 22mcg is specified as the delivered dose (emitted from the inhaler) which is equivalent to the 62.5mcg / 25mcg pre-dispensed dose (contained inside the inhaler) approved in the US and Canada.

Anoro Ellipta is not indicated for the relief of acute bronchospasm or for the treatment of asthma.

In April 2013, a regulatory submission for UMEC/VI under the trade name Anoro Ellipta was filed in Japan and is currently under review.

UMEC/VI is an investigational medicine and is not currently approved anywhere in the world outside of the US and Canada.











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