Posted by Michael Wonder on 01 Apr 2019
Circassia announces FDA approval of Tudorza supplemental new drug application
29 March 2019 - Data showing reduction in COPD exacerbations and no increase in major cardiovascular events vs placebo added to label.
Circassia Pharmaceuticals today announces the US FDA has approved Tudorza’s supplemental new drug application for the inclusion of unique new clinical data in the product’s label. Tudorza is indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) and contains the long-acting muscarinic antagonist aclidinium bromide (400 mcg) administered twice-daily via the breath-actuated inhaler Pressair.
Tudorza’s expanded label now includes data from the phase IV ASCENT study, which was conducted in patients with moderate to very severe COPD and cardiovascular disease and/or significant cardiovascular risk factors.
