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FDA committee backs Boehringer's Spiriva Respimat

August 15, 2014 12:24 AM UTC

FDA's Pulmonary-Allergy Drugs Advisory Committee voted 10-3 that existing data support approval of Spiriva Respimat from Boehringer Ingelheim GmbH (Ingelheim, Germany) to treat chronic obstructive pulmonary disease (COPD). Spiriva Respimat is a propellant-free inhaled mist of tiotropium delivered with Boehringer's Respimat device.

FDA issued a complete response letter for Spiriva Respimat in 2008 in part due to a "numerical increase in deaths" in two 48-week Phase III trials of the product. A subsequent outcomes trial found Spiriva Respimat was non-inferior to Boehringer's Spiriva HandiHaler in the risk of death. Boehringer resubmitted the NDA for Spiriva Respimat in March. The PDUFA date has not been disclosed. ...