BI's Spiriva cleared for COPD by FDA

Germany-based Boehringer Ingelheim has received approval from the US Food and Drug Administration for the use of its Spiriva HandiHaler (tiotropium bromide inhalation powder) as a long-term, once-daily maintenance treatment for bronchospasm associated with chronic obstructive pulmonary disease. The product will be co-promoted by US drug major Pfizer under an agreement signed by the two firms in 2001 (Marketletter April 23, 2001).

Clinical evidence

In clinical trials, Spiriva demonstrated significant bronchodilation that was sustained over the duration of the studies. The agent has also demonstrated significant improvements in lung function over Atrovent (ipratropium bromide), a current first-line therapy for COPD, which were maintained over one year. Clinical studies, both ongoing and completed, include more than 9,400 patients, noted BI.