23rd Sep 2005 15:30
AstraZeneca PLC23 September 2005 ASTRAZENECA SUBMITS NEW DRUG APPLICATION (NDA) TO FDA FOR SYMBICORT(R) MAINTENANCE TREATMENT OF ASTHMA AstraZeneca has announced submission of a New Drug Application (NDA) to the U.S.Food and Drug Administration (FDA) for approval of SYMBICORT(R) (budesonide/formoterol) for the maintenance treatment of asthma. SYMBICORT is a combination of budesonide (an inhaled corticosteroid) andformoterol (a rapid and long lasting ss2-agonist). Combination productscontaining an inhaled corticosteroid and a long-acting ss2-agonist arerecommended by the National Asthma Education and Prevention Program (NAEPP) ofthe National Institute of Health for patients including those whose asthma isuncontrolled on inhaled steroid therapy alone, or for patients whose asthma iscurrently controlled on an inhaled steroid plus a separate inhaled long-actingss2-agonist. The SYMBICORT NDA submission is based on 27 Phase I, II and III trials designedto assess the efficacy and safety of SYMBICORT in a Metered Dose Inhaler (MDI).This application will be for maintenance treatment of asthma in patients age12 and above. The NDA submission seeks approval for two strengths of SYMBICORT(80/4.5 and 160/4.5 microgram). SYMBICORT is currently available in a dry powder inhaler device, Turbuhaler(R),in 93 countries around the world. The current worldwide market for fixedcombination products is estimated to be worth over $6 billion, withapproximately half of this potential market in the U.S. SYMBICORT sales were up21 percent in the first half of 2005, reaching $502 million. In 2003 it wasestimated that 20 million Americans had asthma. Of these, 11 million Americanshad an asthma attack. 23rd September 2005 For further Information: Media Enquiries:Edel McCaffrey, Tel: +44 (0) 207 304 5034Steve Brown, Tel: +44 (0) 207 304 5033 Investor Enquiries:Mina Blair, Tel: +44 (0) 207 304 5084Jonathan Hunt, Tel: +44 (0) 207 304 5087Ed Seage, Tel: +1 302 886 4065Jorgen Winroth, Tel + 1 212 579 0506 - Ends- This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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