ASTRAZENECA RESPONDS TO FDA JOINT ADVISORY COMMITTEES' RECOMMENDATION ON SYMBICORT On 11 December 2008, the Joint Advisory Committees of the U.S. Food and Drug Administration (FDA) - including the Drug Safety & Risk Management Advisory Committee, the Pediatric Advisory Committee, and the Pulmonary-Allergy Drugs Advisory Committee - completed a review of the benefits and risks of asthma medications containing long-acting beta-agonists (LABAs). The committees concluded that the benefits of AstraZeneca's SYMBICORT (budesonide/formoterol fumarate dihydrate), a combination LABA/Inhaled Corticosteroid (ICS) medication, outweigh the risks in adult and adolescent asthma patients. Howard Hutchinson, M.D., Chief Medical Officer of AstraZeneca, said: “The safety and efficacy of SYMBICORT have been demonstrated in numerous clinical trials and from extensive post-marketing use around the world. We are pleased that the joint advisory committees' recommendation confirms our view on the positive benefit-risk profile of SYMBICORT.” The FDA frequently convenes advisory committee meetings to obtain independent expert guidance and recommendations on clinical matters. While the FDA is not required to follow this guidance, the agency usually takes the advice into consideration when rendering its final decisions on pending applications and other public health matters. About SYMBICORT outside the U.S. SYMBICORT (budesonide/formoterol fumarate dihydrate) is a combination of two proven medications - budesonide, an inhaled corticosteroid (ICS), and formoterol, a rapid and long-acting beta2-agonist (LABA). SYMBICORT is approved in over 100 countries for the long-term maintenance treatment of asthma and is available in two different inhalers, SYMBICORT TURBUHALER and SYMBICORT pMDI. SYMBICORT TURBUHALER is a combination therapy indicated for the long-term maintenance treatment of pediatric and adult asthma patients who cannot be adequately controlled on other medications such as inhaled corticosteroids. SYMBICORT should not be used in patients whose asthma can be successfully managed by inhaled corticosteroids along with occasional use of inhaled short-acting beta2-agonists. SYMBICORT TURBUHALER is also indicated for use in patients with Chronic Obstructive Pulmonary Disease (COPD) in 88 countries. - Ends - 11 December 2008 Media Contacts UK: Neil McCrae +44 20 7304 5045 (24 hours) Chris Sampson +44 20 7304 5130 (24 hours) Media Contacts US: Michele Meeker +1 610-662-3589 (24 hours) Investor Enquiries UK: Jonathan Hunt +44 207 304 5087 mob: +44 7775 704032 Mina Blair +44 20 7304 5084 mob: +44 7718 581021 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 Peter Vozzo (MedImmune) +1 301 398 4358 mob: +1 301 252 7518 About AstraZeneca AstraZeneca is a major international healthcare business engaged in research, development, manufacturing and marketing of prescription pharmaceuticals and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of US $29.55 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection product sales. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index. For more information visit www.astrazeneca.com Broadcast quality footage is available to download from the Media section of our website at: http://br.thenewsmarket.com/Astrazeneca/br/Login/LoginPreRegistration.aspx Journalists will be required to register to access this feature.
ASTRAZENECA RESPONDS TO FDA JOINT ADVISORY COMMITTEES' RECOMMENDATION ON SYMBICORT
| Source: AstraZeneca PLC