AstraZeneca Submits sNDA for SYMBICORT® for COPD Treatment

The sNDA submission is based on results from two pivotal efficacy and safety trials with SYMBICORT pressurised meter dose inhaler (pMDI). Both studies were randomized, double-blind, parallel-group, multi-centre trials of patients (N=3,668) with moderate to very severe COPD. Results of the trials found SYMBICORT 160/4.5 (320/9 mcg 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. Of note, both trials showed that SYMBICORT was well tolerated compared to the monoproducts budesonide and formoterol and placebo. The most common adverse events were bronchitis, oral candidiasis and nasopharyngitis, also known as the common cold.

“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,” said Howard Hutchison, Chief Medical Officer, AstraZeneca. “We are confident in the data from the SHINE and SUN trials that support our submission, and we look forward to discussions with the FDA about this potential expanded indication.”


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April 30, 2008

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