Boehringer Ingelheim Announces US Filing for Fixed-Dose Combination Drug
Boehringer Ingelheim recently announced that the US FDA accepted for review the NDA for the fixed-dose combination (FDC) of tiotropium and olodaterol delivered via the Respimat inhaler for the proposed indication of long-term, once-daily maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema. Tiotropium + olodaterol FDC will not be indicated to treat acute deteriorations of COPD or to treat asthma.
Tiotropium + olodaterol FDC is an investigational treatment consisting of the long-acting muscarinic antagonist (LAMA) tiotropium and the long-acting beta agonist (LABA) olodaterol, and is being evaluated for once-daily use via the Respimat inhaler. The Respimat inhaler is a propellant-free inhaler that generates a slow-moving mist.
“The FDA’s acceptance of our application for the FDC of tiotropium and olodaterol is an important milestone for our company, and it reinforces Boehringer Ingelheim’s steadfast commitment to COPD,” said Sabine Luik, MD, Senior Vice President, Medicine & Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc.
The NDA submission for tiotropium + olodaterol FDC is based on results from three global Phase III trials – the 52-week replicate TONADO 1&2 studies (NCT01431274/NCT01431287) and the 6-week cross-over VIVACITO study (NCT01559116). The TONADO 1&2 studies evaluated the long-term effect of tiotropium + olodaterol FDC on lung function, while VIVACITO investigated the 24-hour bronchodilator profile of two tiotropium + olodaterol dose combinations. These studies are part of a large Phase III clinical trial program (TOviTO) for tiotropium + olodaterol FDC, which includes more than 7,000 people living with varying severities of COPD worldwide.
Tiotropium monotherapy, which is marketed as Spiriva HandiHaler (tiotropium bromide inhalation powder) in the US, is a once-daily LAMA indicated for both the maintenance treatment of bronchospasm associated with COPD and to reduce COPD exacerbations. Olodaterol monotherapy – marketed as Striverdi Respimat (olodaterol) Inhalation Spray – is a once-daily LABA indicated for the long-term maintenance bronchodilator treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest US subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies. The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 142 affiliates and more than 47,400 employees. Since it was founded in 1885, the family owned company has been committed to researching, developing, manufacturing, and marketing novel medications of high therapeutic value for human and veterinary medicine. For more information, visit http://www.us.boehringer-ingelheim.com.
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