FDA recommends approval of BI 1744-CL (Boehringer) for COPD

The FDA's Pulmonary-Allergy Drugs Advisory Committee (PADAC) recommended supporting the approval of BI 1744-CL (olodaterol), from Boehringer, as a once-daily maintenance bronchodilator treatment for airflow obstruction in patients with Chronic Obstructive Pulmonary Disease (COPD), including chronic Bronchitis and/or emphysema. If approved by the FDA, it is anticipated that olodaterol will be marketed under the brand name Striverdi Respimat in the US.

The Committee reviewed data from the Phase III olodaterol clinical trial program, including data from the 48-week and 6-week duration trials. These data are part of the NDA being reviewed to establish that olodaterol delivered once daily at the 5 microgram dose showed improvements in lung function, as measured by forced expiratory volume in one second (FEV1), in patients with moderate to very severe COPD compared to placebo and also active comparators. Full results from the Phase III studies included in the olodaterol NDA will be presented at a future medical meeting.