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news.AstraZeneca has submitted a supplemental new drug application to the FDA to seek approval of a new indication for Symbicort inhalation aerosol for the treatment of patients with chronic obstructive pulmonary disease.
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The supplemental new drug application (sNDA) submission is based on results from two pivotal efficacy and safety trials with Symbicort pressurised meter dose inhaler.
Both studies were randomized, double-blind, parallel-group, multi-centre trials of patients (N=3,668) with moderate to very severe chronic obstructive pulmonary disease (COPD). Results of the trials found Symbicort 160/4.5 (320/9mcg 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 COPD.
Howard Hutchison, chief medical officer of AstraZeneca, said: “Symbicort is a combination maintenance treatment for patients with asthma that works rapidly to help improve lung function by reducing inflammation in the lining of the lung.”