FDA Approves Tiotropium for Reducing COPD Exacerbations
By Yael Waknine
Medscape Medical News
December 18, 2009 — The US Food and Drug Administration (FDA) has approved an expanded indication for the inhaled, long-acting anticholinergic agent tiotropium bromide (Spiriva HandiHaler, Boehringer Ingelheim Pharmaceuticals, Inc) for reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD).
The approval was based on data from the Understanding the Potential Long-term Impacts on Function with Tiotropium (UPLIFT) study and a 6-month study conducted in the Veterans Affairs setting. Together the studies involved nearly 8000 patients with COPD, the manufacturer said.
Exacerbations, which can be caused by infection and environmental irritants, were defined as new-onset or increase in symptoms (including cough, sputum, wheezing, or difficulty breathing) that lasted for at least 3 days and required a change in treatment that could include hospitalization.
Although the UPLIFT study did not achieve its primary endpoint of showing a slowed rate of lung function decline relative to placebo, clinical data demonstrated that the addition of tiotropium to preexisting respiratory medications sustained improved lung function during 4 years and reduced COPD exacerbations.
"With today's approval, Spiriva HandiHaler is now the first steroid-free maintenance treatment that has been shown to reduce COPD exacerbations," said Christopher Corsico, MD, vice president, drug regulatory affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "We also are pleased that the product label will now include data from the landmark UPLIFT trial, which provides important information for physicians to consider when making treatment decisions."
Tiotropium previously was approved for the long-term, once-daily maintenance treatment of bronchospasm associated with COPD, including chronic bronchitis and emphysema.
