Boehringer Ingelheim has been boosted by advisors to the US Food and Drug Administration who have backed the mist version of the company’s chronic obstructive pulmonary disease Spiriva.
The agency’s Pulmonary-Allergy Drugs Advisory Committee voted 10-3 that existing data support approval of Spiriva Respimat, an inhaled spray of tiotropium, for long-term, once-daily maintenance treatment of bronchospasm associated with COPD. The committee reviewed results from eight trials, including TIOSPIR, the largest study conducted to date involving over 17,000 patients with COPD.
TIOSPIR showed no difference between Respimat and the approved dry powered form of tiotropium, Spiriva HandiHaler, in risk of death or of first exacerbation, on-treatment all-cause mortality and incidents of cardiovascular adverse events. That study ended safety fears that had led the FDA to reject Spiriva Respimat in 2008 and Boehringer resubmitted the latter in March.
If approved, Spiriva Respimat will provide a choice between a mist and dry powder inhaler for tiotropium and add to its already-stellar sales. Spiriva contributed 1.62 billion euros in the first half of 2014.
