FDA Approves Symbicort

AstraZeneca’s Symbicort (budesonide/formoterol) Treatment For Asthma Approved By The FDA

July 22, 2006 -- AstraZeneca today announced that the U.S. Food and Drug Administration (FDA) has approved Symbicort (budesonide/formoterol) for the maintenance treatment of asthma in patients age 12 and older.

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.

"We are very pleased that the FDA has approved Symbicort in the United States," said David Brennan, Chief Executive Officer, AstraZeneca. "Millions of Americans suffer from asthma and the availability of Symbicort affords them a new opportunity to achieve better asthma control."

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 or 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.

AstraZeneca plans to launch Symbicort in the US in mid 2007.

Asthma is a reversible obstructive lung disease caused by increased reaction of the airways to various stimuli. It is a serious chronic medical condition and can be life-threatening if not properly managed. In 2002, the Centers for Disease Control estimated that nearly 20 million Americans had asthma, and nearly 12 million of these had an attack or episode during the previous year. Despite the availability of many treatments in the United States to treat adults with asthma, the disease is still poorly controlled. Studies have shown that patients experience emergency department (ED) visits, hospitalizations, or attacks at a steady rate. Additionally, asthma patients who have experienced an asthma attack are twice as likely to experience additional exacerbations as other patients. The annual direct healthcare cost of the disease in the US is approximately $10.1 billion. Indirect costs (e.g., lost productivity due to missed days at school or work) add another $8.2 billion, for a total cost of $18.3 billion.

Symbicort received European Mutual Recognition for the treatment of asthma in December 2000 and is currently approved in over 90 countries and has reached more than 5 million patient years outside the United States.

About Astrazeneca

AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of $23.95 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. In the United States, AstraZeneca is a $10.77 billion healthcare business with more than 12,000 employees. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.

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Posted: July 2006

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Symbicort (budesonide and formoterol) FDA Approval History

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