FDA Advisory Committee recommends Spiriva Respimat for treatment of COPD - Boehringer

The FDA Pulmonary Allergy Drugs Advisory Committee (PADAC) voted 10-3 in favour of the Spiriva Respimat (tiotropium bromide) from Boehringer for treatment of COPD. The PADAC unanimously declared the supporting data provided substantial evidence of a clinically meaningful benefit for the drug as a once-daily medicine for COPD. Although the PADAC voted 9-4 the safety data adequately addressed the FDA's concerns with Spiriva Respimat some committee members were concerned at the reports of myocardial infarction associated with the drug.