AstraZeneca submits Symbicort sNDA to US FDA

Anglo-Swedish drug major AstraZeneca has submitted a supplemental New Drug Application to the US Food and Drug Administration seeking approval for a new indication for Symbicort (budesonide/formoterol fumarate dihydrate) inhalation aerosol for the treatment of patients with chronic obstructive pulmonary disease. The agent is currently approved for the long-term maintenance treatment of asthma in patients 12 years and older. The sNDA submission is based on results from two pivotal efficacy and safety trials with Symbicort pressurized meter dose inhaler. Both studies were randomized, double-blind, parallel-group, multicenter trials of patients (N=3,668) with moderate to very severe COPD. Results of the trials found that Symbicort 160/4.5 (320mcg/9mcg bid) met the pre-specified co-primary endpoints and was found to be effective and well-tolerated for up to 12 months in patients with moderate to very severe disease.