WILMINGTON, Del., June 4 /PRNewswire-FirstCall/ -- AstraZeneca (NYSE: AZN) today announced that it submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for approval of a new indication for SYMBICORT(R) (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol for the long-term maintenance treatment of asthma in pediatric patients ages 6 to 11 years old. SYMBICORT is currently approved for the long-term maintenance treatment of asthma in patients 12 years and older.
"Millions of children in the U.S. are affected by asthma(1)," said lead investigator Jeffrey Leflein, MD, Allergy & Immunology Associates of Ann Arbor, Michigan. "SYMBICORT could potentially offer another treatment option for the long-term maintenance of asthma in young children whose condition is not adequately controlled with inhaled corticosteroids alone."
The submission package is based on a robust clinical development program consisting of five active or placebo-controlled Phase III trials assessing the efficacy and safety of SYMBICORT pressurized metered-dose inhaler (pMDI) that included 1,446 children ages 6 to 11 years old with asthma.(2) The proposed starting dose for children (80/9 mcg twice-daily) was studied in one pivotal randomized, double-blind, active-controlled, 12-week study that evaluated 256 children ages 6 to 11 years old with mild-to-moderate persistent asthma previously treated with inhaled corticosteroid therapy.(3) In this study, SYMBICORT was compared to budesonide pMDI and formoterol dry powder inhaler.(3) A second study evaluating this dose included 351 subjects ages 6 to 11 years old.(4) Results from both studies demonstrated that SYMBICORT 80/9 mcg twice daily had a similar safety profile to one of the mono-components, budesonide;(4,5) likewise, results from the first study also found that SYMBICORT 80/9 mcg twice daily had a similar safety profile to its other mono-component, formoterol.(5) The most common adverse events reported were headache, pyrexia, upper respiratory tract infection, nasopharyngitis, and pharyngolaryngeal pain.(2)
"This sNDA submission is another important milestone for SYMBICORT, and we look forward to discussions with the FDA about the potential indication for children," said Howard Hutchinson, Chief Medical Officer, AstraZeneca. "AstraZeneca remains committed to advancing the treatment of asthma in adult and pediatric patients."
About Pediatric Asthma
Asthma is a chronic disease of the lungs that affects children, as well as adults, and it can be life threatening if not properly managed.(6,7) Nearly 9 million children in the U.S. have been diagnosed with asthma at some point in their lives.(1) Asthma is a cause of school absenteeism, accounting for nearly 13 million missed days of school in 2003.(8) It is also the second leading respiratory disease to cause hospitalization in children under the age of 15.(9) According to the National Institutes of Health Guidelines, combination therapy is recommended for children with severe persistent asthma or in those not adequately controlled with medium doses of inhaled corticosteroids alone.(10) The annual direct healthcare cost of the disease for children and adults in the U.S. is approximately $14.7 billion. Indirect costs (e.g., lost productivity due to missed days at school or work) add another $5 billion, for a total cost of $19.7 billion.(11)
SYMBICORT is a combination therapy indicated for the long-term maintenance treatment of asthma in patients 12 years of age and older.(12) Administered twice daily, SYMBICORT is a combination of two proven asthma medications -- budesonide, an inhaled corticosteroid (ICS), and formoterol, a rapid and long-acting beta2-agonist (LABA).(12) SYMBICORT does not replace fast-acting inhalers and should not be used to treat acute symptoms of asthma.(12)
Important Safety Information
Long acting beta2-adrenergic agonists may increase the risk of asthma-related death. Therefore, when treating patients with asthma, SYMBICORT should only be used for patients not adequately controlled on other asthma-controller medications (e.g., low-to-medium dose inhaled corticosteroids) or whose disease severity clearly warrants initiation of treatment with two maintenance therapies. Data from a large placebo-controlled U.S. study compared the safety of another long-acting beta2-adrenergic agonist (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol may apply to formoterol (a long-acting beta2-adrenergic agonist), one of the active ingredients in SYMBICORT.
SYMBICORT is not indicated for the relief of acute bronchospasm.
SYMBICORT should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of asthma.
Particular care is needed for patients who are transferred from systemically active 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 twice daily should not use additional formoterol or other long-acting inhaled beta2-agonists for any reason.
Common adverse events reported in clinical trials, occurring in greater than or equal to 5 percent of patients, regardless of relationship to treatment, include nasopharyngitis, headache, upper respiratory tract infection, pharyngolaryngeal pain, sinusitis, and stomach discomfort.
Please see full Prescribing Information and visit www.MySYMBICORT.com
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 $29.55 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infectious disease medicines. In the United States, AstraZeneca is a $13.35 billion dollar healthcare business with 12,200 employees committed to improving people's lives. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.
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