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Press release from Business Wire

SYMBICORT® (budesonide/formoterol fumarate dihydrate) Long-Term Study Shows Similar Safety Profile When Compared to Budesonide Monotherapy in African-American Patients with Asthma

<p class='bwalignc'> <i>52-week Safety Data Published in The Journal of Allergy and Clinical Immunology</i> </p>

Thursday, May 10, 2012

SYMBICORT® (budesonide/formoterol fumarate dihydrate) Long-Term Study Shows Similar Safety Profile When Compared to Budesonide Monotherapy in African-American Patients with Asthma09:00 EDT Thursday, May 10, 2012 WILMINGTON, Del. (Business Wire) -- AstraZeneca (NYSE:AZN) today announced the publication of data demonstrating that SYMBICORT Inhalation Aerosol 320/9 µg twice daily had a safety profile similar to budesonide pressurized metered-dose inhaler (pMDI)* 320 µg twice daily in a 52-week study in African-American patients with moderate-to-severe persistent asthma. The most common adverse events, regardless of study drug relationship, were headache, nasopharyngitis, sinusitis, and viral upper respiratory tract infection. No unexpected patterns of abnormalities were observed in laboratory, electrocardiographic, or Holter monitoring assessments. These data have been published in the May 1st online edition of TheJournal of Allergy & Clinical Immunology (JACI). More than 22 million Americans are living with asthma, including 2.3+ million African Americans. “These findings provide important information about the use of SYMBICORT in African-American patients with persistent asthma, and may help guide healthcare professionals considering treatment therapies for their appropriate patients with asthma,” said Frank Trudo, Associate Medical Director, AstraZeneca. "This trial is part of AstraZeneca's commitment to studying SYMBICORT in patient populations with disproportionate asthma prevalence." There have been few prior long-term studies evaluating combination inhaled corticosteroid (ICS)/long-acting β2-adrenergic agonist (LABA) combination medications in specific ethnic populations with moderate to severe persistent asthma not adequately controlled on ICSs alone. Results from this 52-week study are commensurate with safety data from the TITAN study, a 12-week study of SYMBICORT in African-American patients, and with previous SYMBICORT studies that included Hispanic and Caucasian patients. Cardiovascular safety sub-analysis results from the present study will be presented at the International American Thoracic Society Conference, being held May 18th-23rd in San Francisco, CA (Abstract #31858). Please see full Prescribing Information, including Boxed WARNING. -ENDS-NOTES TO EDITORSIMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING • WARNING: Long-acting beta2-adrenergic agonists (LABA), such as formoterol, one of the active ingredients in SYMBICORT, increase the risk of asthma-related death. A placebo controlled study with another LABA (salmeterol) showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol is considered a class effect of LABA, including formoterol. Currently available data are inadequate to determine whether concurrent use of inhaled corticosteroids or other long-term asthma control drugs mitigates the increased risk of asthma-related death from LABA. Available data from controlled clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients • When treating patients with asthma, prescribe SYMBICORT only for patients not adequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and LABA. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (eg, discontinue SYMBICORT) if possible without loss of asthma control, and maintain the patient on a long-term asthma control medication, such as an inhaled corticosteroid. Do not use SYMBICORT for patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroidsSYMBICORT is NOT a rescue medication and does NOT replace fast-acting inhalers to treat acute symptoms. It is possible that systemic corticosteroid effects such as hypercorticism and adrenal suppression may occur, particularly at higher doses. Particular care is needed for patients who are transferred from systemically active corticosteroids to inhaled corticosteroids. Deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids. Patients who are receiving SYMBICORT should not use additional formoterol or other LABA for any reason. Due to possible immunosuppression, potential worsening of infections could occur. A more serious or even fatal course of chickenpox or measles can occur in susceptible patients. Excessive beta-adrenergic stimulation has been associated with central nervous system and cardiovascular effects. SYMBICORT, like all products containing sympathomimetic amines, should be used with caution in patients with convulsive disorders, thyrotoxicosis, and cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension. Beta-adrenergic agonist medications may produce hypokalemia and hyperglycemia in some patients. As with other inhaled medications, paradoxical bronchospasm may occur with SYMBICORT. Use with caution in patients with diabetes mellitus. Long-term use of orally inhaled corticosteroids, such as budesonide, a component of SYMBICORT, may result in a reduction in growth velocity and/or a loss of bone mineral density. Glaucoma, increased intraocular pressure, and cataracts have been reported following the inhaled administration of corticosteroids, including budesonide, a component of SYMBICORT. In rare cases, patients on inhaled corticosteroids may present with systemic eosinophilic conditions. SYMBICORT should be administered with caution to patients being treated with MAO inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents. Caution should also be exercised in patients on long-term ketoconazole and other known potent CYP3A4 inhibitors. The most common adverse reactions ≥3% reported in clinical trials included nasopharyngitis, headache, upper respiratory tract infection, pharyngolaryngeal pain, sinusitis, influenza, back pain, nasal congestion, stomach discomfort, vomiting, and oral candidiasis. INDICATIONS SYMBICORT is indicated for the treatment of asthma in patients 12 years and older (also see Boxed WARNING). SYMBICORT is NOT indicated for the relief of acute bronchospasm and should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of asthma. Please see full Prescribing Information, including Boxed WARNING. About the Study The 52-week, randomized, double-blind Phase IIIb safety study included 742 self-reported African-American patients 12 years of age and older with moderate-to-severe persistent asthma previously receiving medium to high-dose inhaled corticosteroids. After two weeks of receiving twice-daily budesonide 320 µg pMDI, patients were randomized to receive twice-daily SYMBICORT 320/9 µg or twice-daily budesonide pMDI 320 µg. Adverse events (AEs) were recorded in electronic diaries and assessed by investigators for a causal relationship to the study medication. Designed as a safety study, no single efficacy variable was considered primary. Spirometric variables, including predose FEV1 and forced vital capacity (FVC), were performed according to American Thoracic Society guidelines (at screening; randomization; days 14 and 45; months 3, 6, 9, and 12) at least 6 hours after albuterol use and approximately 12 hours after study medication use. Daily diary-based measures of asthma control included morning peak expiratory flow (PEF) (L/min), rescue medication use (via inhaler or nebulizer), rescue medication–free days, symptom-free days, and asthma control days (no asthma symptoms or rescue medication use). *Budesonide pressurized metered-dose inhaler (pMDI) is a product that is allowed for use as a clinical study comparator but is not approved for commercialization. About AstraZeneca AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialization of prescription medicines for gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information about AstraZeneca in the U.S. or our AZ&Me™ Prescription Savings programs, please visit: www.astrazeneca-us.com or call 1-800-AZandMe (292-6363). SYMBICORT is a registered trademark, and AZ&Me is a trademark, of the AstraZeneca group of companies. ©2012 AstraZeneca. All rights reserved. 1805204 5/12 AstraZenecaMedia Inquiries USElizabeth Renz, +1 302-885-1936Elizabeth.Renz@astrazeneca.com