30th Apr 2008 07:01
AstraZeneca PLC30 April 2008 AstraZeneca Submits sNDA for SYMBICORT(R) for COPD Treatment AstraZeneca today announced submission of a supplemental New Drug Application(sNDA) to the US Food and Drug Administration (FDA) to seek approval of a newindication for SYMBICORT(R) (budesonide/formoterol fumarate dihydrate)Inhalation Aerosol for the treatment of patients with Chronic ObstructivePulmonary Disease (COPD). SYMBICORT is currently approved for the long-termmaintenance treatment of asthma in patients 12 years and older. The sNDA submission is based on results from two pivotal efficacy and safetytrials with SYMBICORT pressurised meter dose inhaler (pMDI). Both studies wererandomized, double-blind, parallel-group, multi-centre trials of patients (N=3,668) with moderate to very severe COPD. Results of the trials found SYMBICORT160/4.5 (320/9 mcg bid) met the pre-specified co-primary endpoints and was foundto be effective and well-tolerated for up to 12 months in patients with moderateto very severe COPD. Of note, both trials showed that SYMBICORT was welltolerated compared to the monoproducts budesonide and formoterol and placebo.The most common adverse events were bronchitis, oral candidiasis andnasopharyngitis, also known as the common cold. "SYMBICORT is a combination maintenance treatment for patients with asthma thatworks rapidly to help improve lung function by reducing inflammation in thelining of the lung," said Howard Hutchison, Chief Medical Officer, AstraZeneca."We are confident in the data from the SHINE and SUN trials that support oursubmission, and we look forward to discussions with the FDA about this potentialexpanded indication." 30 April 2008 Media Enquiries:Steve Brown +44 207 304 5033 (24 hours)Chris Sampson +44 20 7304 5130 (24 hours)Neil McCrae +44 207 304 5045 (24 hours) Investor Enquiries UK: Jonathan Hunt +44 207 304 5087 mob: +44 7775 704032Mina Blair +44 20 7304 5084 mob: +44 7718 581021Karl Hard +44 207 304 5322 mob: +44 7789 654364 Investor Enquiries US: Ed Seage +1 302 886 4065 mob: +1 302 373 1361Jorgen Winroth +1 212 579 0506 mob: +1 917 612 4043Peter Vozzo (MedImmune) +1 301 398 4358 mob: +1 301 252 7518 About COPD More than 12 million people in the United States suffer from COPD, and it is thefourth leading cause of death in the nation. Some estimates also suggest that12 million more people have COPD but are undiagnosed. COPD is a term referringto two serious lung diseases - emphysema and chronic bronchitis - that cause aperson's airways to become inflamed over time, making it difficult to breathenormally. Common symptoms include shortness of breath, chronic cough, wheezingand excess mucus. To reduce exacerbations and improve lung function and healthstatus, the Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD)recommends the use of combination treatments with an inhaled corticosteroid(ICS) and long-acting beta2-agonist (LABA), in addition to other treatmentoptions. COPD is a progressive disease, which means people with COPD can expectlung function to worsen over time. When symptoms are severe, it can be difficultfor a person to perform simple, daily tasks and some people may eventuallyrequire supplemental oxygen and may have to rely on mechanical respiratoryassistance. About SYMBICORT SYMBICORT is a combination therapy indicated for the long-term maintenancetreatment of asthma in patients 12 years of age and older. Administered twicedaily, SYMBICORT is a combination of two proven asthma medications - budesonide,an inhaled corticosteroid (ICS), and formoterol, a rapid and long-actingbeta2-agonist (LABA). SYMBICORT does not replace fast-acting inhalers and shouldnot be used to treat acute symptoms of asthma. About AstraZeneca AstraZeneca is a major international healthcare business engaged in research,development, manufacturing and marketing of prescription pharmaceuticals andsupplier for healthcare services. AstraZeneca is one of the world's leadingpharmaceutical companies with healthcare sales of US $29.55 billion and is aleader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncologyand infection product sales. AstraZeneca is listed in the Dow JonesSustainability Index (Global) as well as the FTSE4Good Index. Broadcast quality footage is available to download from the Media section of ourwebsite at: http://br.thenewsmarket.com/Astrazeneca/br/Login/LoginPreRegistration.aspx Journalists will be required to register to access this feature. - Ends - This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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