FDA批准慢性阻塞性肺病新药StioltoRespimat

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                                                                           2015年5月26日，勃林格殷格翰公司宣布，美国FDA批准了其StioltoRespimat（tiotropiumbromide-olodaterol，噻托溴铵-奥达特罗）吸入喷雾剂，它被用于慢性阻塞性肺病（COPD），包括慢性支气管炎和/或肺气肿的气道阻塞每日一次长期维持治疗。

                       StioltoRespimat不适用于治疗哮喘或慢性阻塞性肺病急性加剧。

                       COPD，包括慢性支气管炎和肺气肿，是一种严重的但可治疗肺病。超过1500万美国人患有此症，但估计有多达45％未被诊断出。通常当患者被确诊时肺功能已显著受损。COPD综合征会对患者的呼吸能力产生负面影响，尤其在进行日常活动时。

                       勃林格殷格翰制药公司临床开发和医疗事务副总裁DannyMcBryan博士指出：“新近对一系列有里程碑意义的研究的综述指出：COPD的早期阶段肺功能丧失已经加速，然而没有一种治疗手段可以减慢肺功能减退速度。在诊断明确后即以StioltoRespimat维持治疗可改善肺功能。”​

                        U.S. Food and Drug Administration (FDA) approved once-daily Stiolto™ Respimat® (tiotropium bromide and olodaterol) Inhalation Spray. It has been approved as a long-term, once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Stiolto™ Respimat® is not indicated to treat asthma or acute deterioration of COPD.

                        About Stiolto™ Respimat®

                        “Stiolto™ Respimat® produced greater lung function improvements in terms of FEV1 compared to tiotropium and olodaterol alone in patients with COPD across a range of severities (GOLD 2 to 4),”6,7,8 said Richard Casaburi, MD, PhD, professor and associate chief, Division of Respiratory and Critical Care Physiology and Medicine, Harbor-UCLA Medical Center. “As a clinician, I am pleased to have a new treatment option to offer my patients.”

                        Tiotropium is a long-acting anticholinergic and the active ingredient in Spiriva® Respimat® and Spiriva® HandiHaler®. Since its approval more than 10 years ago, Spiriva® has extensive clinical experience with over 40 million patient-years and more than 200 clinical trials. Spiriva® is the most prescribed COPD maintenance treatment worldwide.

                         Olodaterol, marketed as Striverdi® Respimat®, is a long-acting beta2-agonist that was specifically designed to complement the efficacy of Spiriva®. Olodaterol has a fast onset of action that has a clinically meaningful improvement in airflow five minutes after the first dose.

                        “The approval of Stiolto™ Respimat® in the U.S. marks an important milestone in our ongoing commitment to provide effective solutions for patients with COPD,” said Klaus Dugi, Chief Medical Officer, Boehringer Ingelheim. “Building on years of trusted experience with Spiriva®, Stiolto™ Respimat® provides even further benefits than Spiriva® alone and will offer a valuable new treatment option for patients and physicians. We look forward to the decision from the European regulatory authorities soon.”

                           The approval is based on data from the pivotal Phase III TONADO® 1&2 trials (NCT01431274/NCT01431287), which evaluated more than 5,000 COPD patients and showed Stiolto™ Respimat® provides statistically significant improvements in lung function over tiotropium and olodaterol alone.6 The trials, part of the TOviTO® clinical trial programme involving more than 15,000 COPD patients worldwide, also showed Stiolto™ Respimat® has a safety profile similar to tiotropium or olodaterol alone.6

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