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 作者: imus9425 时间: 2015-7-20 06:46
提示: 作者被禁止或删除 内容自动屏蔽作者: maojy 时间: 2015-7-20 14:26
