BI COPD fixed-dose combo under FDA review
This article was originally published in Scrip
Seeking to grow its already successful chronic obstructive pulmonary disease (COPD) product line, Boehringer Ingelheim on 19 August revealed the FDA had accepted for review the new drug application (NDA) for the firm's fixed-dose combination (FDC) of tiotropium and olodaterol, which is intended to be delivered with the company's Respimat inhaler.
Just last week, an FDA panel of outside advisers gave a thumbs up to BI's experimental COPD drug Spiriva Respimat, whose active ingredient is one of the components in the company's FDC product –tiotropium, a long-acting muscarinic antagonist (LAMA) – and which uses the same inhaler device (scripintelligence.com, 15 August 2014).
Tiotropium also is the active ingredient in BI's Spiriva HandiHaler, also a COPD drug.
The other agent in the FDC, olodaterol, is the active ingredient in BI's most recently approved COPD drug Striverdi Respimat, a long-acting beta-agonist (LABA), which won approval on 31 July (scripintelligence.com, 1 August 2014).
The Respimat inhaler also is used in BI's Combivent Respimat (ipratropium bromide/albuterol sulfate), also a COPD drug, which initially was approved in 1996.
Respimat has a relatively slow aerosol delivery, high-fine particle fraction of the spray, delivered dose largely independent of patients' inspiratory flow, a propellant-free environmentally friendly formulation, convenience of a multi-dose inhaler and technological advances that facilitate the proper use by the patent, such as a dose-indicator and a locking mechanism, which prevents fail-off of dosing, according to BI.
The FDA is considering the LAMA/LABA FDC product as a long-term, once-daily maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema. The product, however, will not be indicated to treat acute deteriorations of COPD or to treat asthma, BI emphasized.
The NDA for the tiotropium/olodaterol FDC was based on results from three global Phase III trials – the 52-week replicate TONADO 1 and 2 studies and the 6-week cross-over VIVACITO trial.
The TONADO studies evaluated the long-term effect of tiotropium/olodaterol FDC on lung function, while VIVACITO investigated the 24-hour bronchodilator profile of the dose combinations.
The studies were part of a large Phase III clinical trial program, known as TOviTO, for the FDC product, which included more than 7,000 COPD patients worldwide with varying severities of the disease.