AstraZeneca PLC Says FDA Approves Symbicort For Asthma Treatment

LONDON -(Dow Jones)- AstraZeneca Monday announced the U.S. Food and Drug Administration (FDA) has approved SYMBICORT(R) (budesonide/formoterol) for the maintenance treatment of asthma in patients age 12 and older. AstraZeneca plans to launch SYMBICORT in the U.S. in mid 2007. SYMBICORT is a twice-daily asthma therapy combining budesonide, an inhaled corticosteroid, and formoterol, a rapid and long-acting beta2-agonist into one inhaler.

SYMBICORT will be available in a pressurized metered dose inhaler (pMDI), the most commonly used and prescribed delivery device in the U.S. market. The United States is the first country where SYMBICORT will be available in this type of device.

The FDA has approved two dose strengths for SYMBICORT, 80/4.5 and 160/4.5 mcg of budesonide and formoterol, respectively. Combination therapy, specifically adding long-acting inhaled beta-agonists to inhaled corticosteroids for long-term control and prevention of symptoms in moderate and severe-persistent asthma is recommended by National Asthma Education and Prevention Program (NAEPP) of The National Institutes of Health ( NIH).

The SYMBICORT submission was based on 27 Phase I, II, and III trials designed to assess the efficacy and safety of SYMBICORT in a metered dose inhaler.

The approved indication is based on data from two pivotal double blind, placebo-controlled, 12-week trials involving 1,076 patients in the United States, age 12 and over.

These studies showed that both dosage strengths of SYMBICORT produced a greater improvement in lung function compared to the same doses of budesonide and formoterol administered alone or placebo.

In addition, these studies demonstrated a more rapid improvement in lung function compared to budesonide and placebo. Significant improvement in lung function occurred within 15 minutes of beginning treatment with Symbicort.

SYMBICORT is not indicated for the relief of acute bronchospasm.

(END) Dow Jones Newswires 07-24-06 0245ET Copyright (c) 2006 Dow Jones & Company, Inc.