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New sNDA for AZ's Symbicort

AstraZeneca has submitted a supplemental new drug application to the US Food and Drug Administration for its COPD product, Symbicort
AstraZeneca (AZ) has submitted a supplemental new drug application (sNDA) to the US Food and Drug Administration (FDA) for its COPD product, Symbicort.

Results from two pivotal efficacy and safety trials showed that Symbicort (budesonide/formoterol) could be a potential inhalation aerosol treatment for patients with chronic obstructive pulmonary disease (COPD). Patients with moderate-to-severe COPD were given Symbicort during the studies. According to AZ, the medication was well tolerated and efficacious.

Howard Hutchinson, chief medical officer at AZ, said: "We are confident in the data from Shine and Sun trials that support our submission and we look forward to discussions with the FDA about this potential expanded indication."

Symbicort is currently approved in the US for the treatment of asthma in patients over 12-years-old to help manage their condition. AZ said that the drug met pre-specified endpoints during clinical studies, prompting the firm to file the sNDA.

2nd May 2008

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