24th Jul 2006 07:02
AstraZeneca PLC24 July 2006 AstraZeneca's SYMBICORT(R) (budesonide/formoterol) Treatment For Asthma Approved By The FDA AstraZeneca has announced that the U.S. Food and Drug Administration (FDA) hasapproved SYMBICORT(R) (budesonide/formoterol) for the maintenance treatment ofasthma in patients age 12 and older. SYMBICORT is a twice-daily asthma therapy combining budesonide, an inhaledcorticosteroid, and formoterol, a rapid and long-acting beta2-agonist into oneinhaler. 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 beavailable in this type of device. The FDA has approved two dose strengths forSYMBICORT, 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 Americanssuffer from asthma and the availability of SYMBICORT affords them a newopportunity to achieve better asthma control." Combination therapy, specifically adding long-acting inhaled beta-agonists toinhaled corticosteroids for long-term control and prevention of symptoms inmoderate and severe-persistent asthma is recommended by National AsthmaEducation 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 toassess the efficacy and safety of SYMBICORT in a metered dose inhaler. Theapproved indication is based on data from two pivotal double blind,placebo-controlled, 12-week trials involving 1,076 patients in the UnitedStates, age 12 and over. These studies showed that both dosage strengths ofSYMBICORT produced a greater improvement in lung function compared to the samedoses of budesonide and formoterol administered alone or placebo. In addition,these studies demonstrated a more rapid improvement in lung function compared tobudesonide and placebo. Significant improvement in lung function occurred within15 minutes of beginning treatment with Symbicort. SYMBICORT is not indicatedfor 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 ofthe airways to various stimuli. It is a serious chronic medical condition andcan be life-threatening if not properly managed. In 2002, the Centers forDisease Control estimated that nearly 20 million Americans had asthma, andnearly 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 adultswith asthma, the disease is still poorly controlled. Studies have shown thatpatients experience emergency department (ED) visits, hospitalizations, orattacks at a steady rate. Additionally, asthma patients who have experienced anasthma attack are twice as likely to experience additional exacerbations asother patients. The annual direct healthcare cost of the disease in the US isapproximately $10.1 billion. Indirect costs (e.g., lost productivity due tomissed 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 inDecember 2000 and is currently approved in over 90 countries and has reachedmore than 5 million patient years outside the United States. ABOUT ASTRAZENECA AstraZeneca is a major international healthcare business engaged in theresearch, development, manufacture and marketing of prescription pharmaceuticalsand the supply of healthcare services. It is one of the world's leadingpharmaceutical companies with healthcare sales of $23.95 billion and leadingpositions in sales of gastrointestinal, cardiovascular, neuroscience,respiratory, oncology and infection products. In the United States, AstraZenecais a $10.77 billion healthcare business with more than 12,000 employees.AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well asthe FTSE4Good Index. For more information about AstraZeneca, please visit www.astrazeneca.com 24 July 2006 Media Enquiries: Edel McCaffrey, Tel: +44 (0) 207 304 5034Steve Brown, Tel: +44 (0) 207 304 5033 Investor Relations: Mina Blair, Tel: +44 (0) 207 304 5084Jonathan Hunt, Tel: +44 (0) 207 304 5087Jorgen Winroth, Tel: +1 (212) 579 0506Ed Seage, Tel: +1 302 886 4065 -Ends- This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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