FDA advisory panel backs Boehringer's COPD drug olodaterol

In a 15 to one vote with one abstension, the US Food and Drug Administration’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) yesterday recommended that clinical data included in German independent pharma major Boehringer Ingelheim’s New Drug Application provide substantial and convincing evidence to support the approval of olodaterol as a once-daily maintenance bronchodilator treatment 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 USA.

Post-marketing studies recommended

The Committee also voted affirmatively that data showed the efficacy and safety of olodaterol supports approval of the 5mcg dose. However, panelists said Boehringer Ingelheim should also undertake post-marketing studies to monitor benign and malignant tumors that developed in some people taking the drug. Of those taking olodaterol in a clinical trial, 14 on a 5mcg dose developed tumors, as did 19 on a 10mcg dose. Nine people on placebo developed the malignancies as well.