勃林格殷格翰向欧盟提交tiotropium Respimat®扩大适应症申请

勃林格殷格翰（Boehringer Ingelheim）11月13日宣布，已向欧盟提交了Spiriva® Respimat®（tiotropium，通用名：噻托溴铵，商品名：Spiriva，思力华）的扩大适应症申请，寻求批准该药用于治疗18岁及以上成人哮喘（asthma）患者的治疗。

tiotropium Respimat®的欧洲上市许可申请（MA），是基于UniTinA哮喘III期临床试验项目的结果，该项目共涉及全球超过150个站点4000多名患者，旨在评价tiotropium Respimat®用于哮喘患者的疗效和安全性。

该项目中获得的首批数据来自PrimoTinA-asthma研究，证明了tiotropium用于经至少ICS/LABA疗法后仍存在哮喘症状的患者中的疗效和安全性。数据表明，与安慰剂相比，tiotropium Respimat®能够显著延长距离首次严重哮喘发作的时间，以及首次哮喘恶化的时间。

目前，噻托溴铵（tiotropium）已获批用于慢性阻塞性肺病（COPD）的治疗，全面临床数据来自190多个噻托溴铵COPD试验。

英文原文：Boehringer Ingelheim submits applications in Europe to extend the indication for the use of tiotropium Respimat® to the treatment of asthma in adults aged 18 years and over

Ingelheim, Germany, November 13, 2013 (00:01 CET) – Boehringer Ingelheim today announced submission of applications to extend the indication for the use of tiotropium (Spiriva®) Respimat® to the treatment of asthma in adults aged 18 years and over.

"Our extensive studies have demonstrated that tiotropium Respimat® has the potential to be an effective new treatment option which can provide benefits to, and improve outcomes for, adult patients with asthma.  Furthermore, we look forward to results from the paediatric UniTinA-asthma® Phase III studies which are anticipated to become available in 2014,4" said Professor Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim.

"At least 40% of patients with asthma remain symptomatic and may experience frightening and life-threatening asthma exacerbations (attacks), despite using the available therapeutic options, and we believe that tiotropium, once approved, can help address this clear unmet medical need," Professor Dugi continued.

The European Marketing Authorisation (MA) applications for tiotropium Respimat® are based on results from the UniTinA-asthma® Phase III clinical trial programme which involves more than 4,000 patients in over 150 sites globally.

The UniTinA-asthma® clinical trial programme was designed to evaluate the efficacy and safety of tiotropium Respimat® in patients with asthma. UniTinA-asthma® programme includes a total of 11 Phase III studies investigating tiotropium Respimat® added to standard treatment in adults, adolescents and children (age 1+) with persistent asthma across the spectrum of asthma severity.5

The first data to come from the UniTinA-asthma® Phase III clinical trial programme were the PrimoTinA-asthma® studies, which demonstrated the efficacy and safety of tiotropium in asthma patients who remained symptomatic despite treatment with at least ICS/LABA therapy.1 Data from the PrimoTinA-asthma® studies, which have since been published in the New England Journal of Medicine, showed that the addition of tiotropium Respimat® significantly increased time to first severe asthma exacerbation, as well as time to first episode of asthma worsening compared with placebo (standard treatment).1

Data from the MezzoTinA-asthma® Phase III twin studies, which were presented for the first time at the European Respiratory Society (ERS) Annual Congress (7-11 September 2013), were also included in the European MA applications for tiotropium Respimat® in asthma.6,7 The MezzoTinA-asthma® Phase III twin studies showed that, in asthma patients who remain symptomatic despite moderate-dose maintenance ICS therapy, the addition of tiotropium Respimat® significantly improves lung function, provides sustained bronchodilation over 24 hours and provides a statistically significant and clinically relevant improvement in asthma control.6,7

Tiotropium is already approved for the treatment of COPD, with comprehensive clinical trial data from more than 190 tiotropium COPD trials.3 In-market experience with tiotropium since its introduction via HandiHaler® 10 years ago includes more than 31 million patient-years of real life experience‡ to support its efficacy and safety profile.9