勃林格殷格翰COPD新药Striverdi® Respimat®获欧盟首批国家批准

勃林格殷格翰（Boehringer Ingelheim）宣布，慢性阻塞性肺病（COPD）新药Striverdi® Respimat®（olodaterol）上市许可申请（MAA）已成功完成在欧盟的审查程序，该药已获欧盟首批国家英国、丹麦、冰岛的批准。

该药的获批，是基于III期临床项目的数据，该项目涉及3500多名中度至极重度COPD患者（GOLD肺活量水平2-4级），数据表明，与平常护理相比，每日一次的Striverdi® Respimat®能够显著改善患者的生活质量。该项目证实，olodaterol是名副其实的每日一次（a true once-daily）长效β2激动剂药物，能够为COPD患者提供24小时的支气管扩张。

随着审查的积极结果，Striverdi® Respimat®将陆续获得欧盟/欧洲经济区（EU/EEA）其他国家的监管批准。

新药Striverdi® Respimat®是一种速效、长效支气管扩张剂，用于COPD患者的维持治疗。作为一种高度选择性吸入性长效β2-拮抗剂（LABA），olodaterol在首个剂量给药后5分钟内便能够提供显著的支气管扩张作用，并能够持续改善FEV1超过24小时。

关于olodaterol：

olodaterol是一种高度选择性、长效β2拮抗剂（LABA），做为每日一次的吸入性疗法，开发用于COPD患者的维持治疗。该药已获加拿大和俄罗斯批准，在美国及其他国家的监管审查正在进行中。

英文原文：New once-daily Striverdi* (olodaterol) Respimat® gains approval in first EU countries

Boehringer Ingelheim today announced the successful completion of the review process of the Marketing Authorisation Application for Striverdi® Respimat® in the European Union for patients with chronic obstructive pulmonary disease (COPD).

First approvals of Striverdi® Respimat® in United Kingdom, Denmark and Iceland are based on data from the Phase III clinical trial programme involving more than 3,500 patients with moderate to very severe COPD (GOLD spirometric level 2-4). Following the positive outcome of the review process, further national approvals in EU/EEA countries will follow in due course.

Long-lasting anticholinergic bronchodilators such as Spiriva® (tiotropium) are established as base-line maintenance therapy in the treatment of COPD.

The new Striverdi® Respimat® is both a fast-acting and long-lasting bronchodilator for the maintenance treatment of patients with COPD.

The highly selective inhaled long-acting ß2-agonist (LABA), olodaterol delivers significant bronchodilator effects within 5 minutes after the first dose2 and provides sustained improvement in FEV1 over 24 hours.

The Striverdi® phase III programme showed that, compared to usual care alone, lung function improvements with once-daily Striverdi® Respimat® translated into significant improvements in patients’ quality of life, as measured by the reduction in their St George’s Respiratory Questionnaire (SGRQ) total score.

"The improvements in lung function and quality of life seen with once-daily Striverdi® Respimat® are remarkable when you consider that patients in the control group were continuing with their usual care background therapies, including long- and short-acting anticholinergics, short-acting beta agonists, inhaled corticosteroids and xanthines. We are very pleased with these results and are committed to bringing Striverdi® Respimat® to patients worldwide who need an additional treatment option," said Professor Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim.

"Boehringer Ingelheim has designed Striverdi® Respimat® as a possible future combination partner for Spiriva® to provide additional bronchodilation in the maintenance treatment of COPD," Professor Dugi continued.

"Results from our Phase III ANHELTO® studies further evaluating the efficacy and safety of a free combination of tiotropium plus olodaterol are due to be reported in early 2014. These trials are expected to show that many COPD patients will experience clinically meaningful improvements in their quality of life by combining olodaterol with tiotropium."

"In addition, we are currently undertaking a large global Phase III clinical trial programme in COPD - TOviTO® - to investigate the efficacy and safety of a once-daily fixed-dose combination of tiotropium and olodaterol using the Respimat® inhaler."

"Striverdi® Respimat® has the potential to be an effective new treatment option for COPD patients and represents the next step in a series of important advances from our robust pipeline of respiratory treatments. The ANHELTO® and TOviTO® trials together will give us a robust data package to support the combination of tiotropium and olodaterol," concluded Professor Dugi.
About olodaterol
Olodaterol is a highly selective, long-acting beta2-agonist (LABA) for the once-daily maintenance bronchodilator treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema. It is approved for use in the treatment of COPD in Canada and Russia; approval and regulatory reviews by health authorities in the US and other countries worldwide are pending.

Phase III trials have shown that the addition of Striverdi® Respimat® once-daily over 48 weeks achieved statistically significant improvements in lung function vs. usual care alone (p<0.05),1-3 which were comparable to those shown with formoterol Aerolizer® 12 µg twice-daily.2

In addition, the lung function improvements with once-daily Striverdi® Respimat® resulted in more COPD patients achieving clinically meaningful improvements in quality of life compared to usual care.3
A responder analysis showed that, compared to usual care alone, a statistically significant, greater number of COPD patients treated with Striverdi® Respimat® had a decrease in their SGRQ§ total score greater than the minimal clinically important difference (MCID) of 4 units (P<0.001).3

Safety data from the four 48-week Phase III parallel pivotal studies: two comparing olodaterol Respimat® vs. usual care alone and two comparing olodaterol Respimat® vs. formoterol Aerolizer® twice-daily, showed that, overall, the frequency of adverse events (AE) experienced with olodaterol Respimat® was comparable to both placebo and the active comparator formoterol.5 The most common AE was COPD exacerbations.5

Boehringer Ingelheim is developing olodaterol as a combination partner for tiotropium to provide additional bronchodilation in the maintenance treatment of patients with COPD. Combining a long-acting anticholinergic (LAMA) and a LABA has the potential to deliver increased bronchodilatory benefits in COPD symptoms and consistency of treatment response, compared to monotherapy.6,7

About SPIRIVA® (tiotropium bromide) in COPD

SPIRIVA®, a long-acting anticholinergic medication, is the first inhaled maintenance treatment to provide significant and sustained improvements in lung function with once-daily dosing. SPIRIVA® positively impacts the clinical course of COPD, helping to change the way patients live with their disease.8 Since SPIRIVA® was first introduced over ten years ago, it has become the most prescribed maintenance treatment for COPD worldwide. SPIRIVA® helps COPD patients breathe more easily by opening narrowed airways and helping to keep them open for 24 hours. It works through targeting of a dominant reversible mechanism of COPD – cholinergic bronchoconstriction.

SPIRIVA® is delivered via HandiHaler®, a breath-actuated, single-dose dry powder inhaler, or by the SPIRIVA® Respimat® Soft MistTM Inhaler.