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AstraZeneca Submits an sNDA for SYMBICORT(R) for COPD Indication
Date:4/30/2008

WILMINGTON, Del., April 30 /PRNewswire-FirstCall/ -- AstraZeneca (NYSE: AZN) today announced that it submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for approval of a new indication for SYMBICORT(R) (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol for the treatment of patients with Chronic Obstructive Pulmonary Disease (COPD). SYMBICORT is currently approved for the long-term maintenance treatment of asthma in patients 12 years and older.

"COPD is a serious, debilitating lung disease affecting 12 million Americans,(1)" said lead investigator Dr. Donald Tashkin of the University of California, Los Angeles (UCLA). "If SYMBICORT receives approval from the FDA to help manage COPD, it could offer the millions of people living with this disease a new treatment option."

The sNDA submission is based on results from two pivotal efficacy and safety trials, SHINE and SUN, with SYMBICORT pressurized metered dose inhaler (pMDI).(2),(3) Of note, both trials showed a safety profile consistent with the established profiles for this product and its mono-components.(2),(3) The most common adverse events found in these trials were bronchitis, oral candidiasis, viral upper respiratory tract infection and nasopharyngitis, also known as the common cold.(2),(3)

SHINE Study Results

-- 6-month randomized, double-blind, parallel-group, multi-center trial of

patients (N=1,704) with moderate to very severe COPD.(3)

-- SYMBICORT 160/4.5 micrograms (mcg) two puffs twice a day demonstrated a

statistically significantly greater increase from baseline in average

pre-dose FEV1 compared with formoterol 4.5 and in average post-dose

FEV1 compared with budesonide 160, with maintenance of effect for both

comparisons over the 6-month treatment period.(3)

-- SYMBICORT pMDI 160/4.5 also demonstrated a significant increase from

baseline f
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SOURCE AstraZeneca
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