FDA Approves Symbicort for Chronic Obstructive Pulmonary Disease

Monday, 2 March 2009 AstraZeneca today announced that the U.S. Food and Drug Administration (FDA) has approved SYMBICORT (budesonide/formoterol fumarate dihydrate) 160/4.5 mcg for the twice daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. The FDA approval is based on results from two pivotal clinical trials, SHINE (6-month) and SUN (12-month), which found SYMBICORT significantly improved lung function within five minutes of the first dose and sustained that lung function improvement for the duration of the studies. SYMBICORT pMDI (pressurized metered-dose inhaler) has been available in the U.S. since June 2007 for the long-term maintenance treatment of asthma in patients 12 years of age and older. “More than 12 million Americans with COPD struggle each day to live with the debilitating symptoms of COPD,” said Dr. Howard Hutchinson, Chief Medical Officer, AstraZeneca. “With the approval of SYMBICORT in COPD, patients have a new treatment option that can deliver long-term lung function improvement and daily symptom control, together with a rapid onset of action.” COPD is a disorder encompassing two serious lung diseases – emphysema and chronic bronchitis – which result in chronic airway inflammation and progressive loss of lung function, making it difficult to breathe normally. About SYMBICORT Symbicort is approved for use in the treatment of COPD in 91 countries worldwide. About AstraZeneca AstraZeneca is a major international healthcare business engaged in the research, development, manufacturing and marketing of meaningful prescription medicines and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of US$ 31.6 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infectious disease medicines. For more information about AstraZeneca, please visit: www.astrazeneca.com . Media Enquiries UK: Chris Sampson +44 20 7304 5130 (24 hours) Neil McCrae +44 20 7304 5045 (24 hours) Sarah Lindgreen +44 20 7304 5033 (24 hours) Media Enquires US: Katie Neff +1 302 885 9960 Emily Denney +1 302 885 3451 Investor Enquiries UK: Jonathan Hunt +44 207 304 5087 mob: +44 7775 704032 Karl Hard +44 207 304 5322 mob: +44 7789 654364 Investor Enquiries US: Ed Seage +1 302 886 4065 mob: +1 302 373 1361 Jorgen Winroth +1 212 579 0506 mob: +1 917 612 4043 tags Corporate and financial AstraZeneca Websites This website is intended for people seeking information on AstraZeneca's worldwide business. Our country sites can be located in the AZ Network. Veeva ID: Z4-8411 Date of next review: August 2020 Resources All resources Open Innovation Externally sponsored scientific research Medical Information for HCPs US prescription assistance programmes Global clinical trials information Medicines Report a possible side effect Pearl Therapeutics Quick links Media Investor Relations Partnering Careers Sustainability Modern Slavery Statement Supplier information Social Media Community Guidelines Social Media LinkedIn Twitter YouTube Instagram Glassdoor Facebook utility links Legal notice and Terms of Use Privacy notice Cookie policy Site map Contact us © AstraZeneca 2020 You are now leaving AstraZeneca.com You have selected a link that will take you to a site maintained by a third party who is solely responsible for its contents. AstraZeneca provides this link as a service to website visitors. AstraZeneca is not responsible for the privacy policy of any third party websites. We encourage you to read the privacy policy of every website you visit. Click ‘cancel’ to return to AstraZeneca’s site or ‘continue’ to proceed. Cancel Continue ? Important notice for users You are about to access AstraZeneca historic archive material. Any reference in these archives to AstraZeneca products or their uses may not reflect current medical knowledge and should not be used as a source of information on the present product label, efficacy data or safety data. Please refer to your approved national product label (SmPC) for current product information. I have read this warning and will not be using any of the contained product information for clinical purposes. I disagree I agree ? ?

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