FDA panel recommends Boehringer drug for the maintenance treatment of COPD

There was good news late yesterday for German family-owned pharma major Boehringer Ingelheim, when an advisory panel of the US Food and Drug Administration came back with a majority vote to recommend approval of the firm’s lung disease drug.

The FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) voted [10 yes, 3 no] that existing data supports approval of Boehringer Ingelheim’s investigational tiotropium bromide inhalation spray for long-term, once-daily maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema and to reduce exacerbations in COPD patients. If approved by the FDA, the proposed proprietary name for tiotropium bromide inhalation spray will be Spiriva Respimat.

The Advisory Committee voted that existing data supports approval after a review of the results from eight efficacy clinical trials in which 8,700 patients were treated with tiotropium in the RESPIMAT device. One of these trials, TIOSPIR, the largest clinical trial conducted to date in patients with COPD, collected data from more than 17,000 COPD patients from 50 countries. The Advisory Committee provides non-binding recommendations for consideration by the FDA, which makes the final decision on approval.