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)
About SYMBICORT
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 http://www.MySYMBICORT.com
About AstraZeneca
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.
For more information visit http://www.astrazeneca-us.com.
References
(1.) Centers for Disease Control and Prevention. National Center for
Health Statistics. Summary Health Statistics for U.S. Children:
National Health Interview Survey, 2003. Retrieved on 22 May 2008.
http://www.cdc.gov/nchs/data/series/sr_10/sr10_223.pdf.
(2.) sNDA: SYMBICORT Pediatric Indication Submission, AstraZeneca LP.
June 3, 2008.
(3.) Murphy, K.R., Pearlman, D.S., Uryniak, T., O'Brien, C.D.,
Mezzanotte, W.S. Efficacy of Budesonide/Formoterol Pressurized
Metered-Dose Inhaler (BUD/FM pMDI) in Children with Asthma
Previously Treated with Inhaled Corticosteroids (ICSs) [poster].
American Thoracic Society, May 16-21, 2008, Toronto, Canada. Poster
#K66.
(4.) Noonan, M.J., Eid, N.S., Uryniak, T., O'Brien, C.D. Safety of
Once-Daily (qd) Budesonide/Formoterol Pressurized Metered-Dose
Inhaler (BUD/FM pMDI) in Children and Adolescents with Asthma
Previously Stable on Twice-Daily (bid) BUD/FM pMDI [poster].
American Thoracic Society, May 16-21, 2008, Toronto, Canada. Poster
#K71.
(5.) Pearlman, D.S., Murphy, K.R., Uryniak, T., O'Brien, C.D.,
Mezzanotte, W.S. Safety of Budesonide/Formoterol Pressurized
Metered-Dose Inhaler (BUD/FM pMDI) in Children with Asthma
Previously Treated with Inhaled Corticosteroids (ICSs) [poster].
American Thoracic Society, May 16-21, 2008, Toronto, Canada. Poster
#K67.
(6.) Center for Disease Control and Prevention. Advance Data from Vital
and Health Statistics. The State of Childhood Asthma, United
States, 1980-2005. Retrieved on 22 May 2008.
http://www.cdc.gov/nchs/data/ad/ad381.pdf.
(7.) Centers for Disease Control and Prevention. National Surveillance
for Asthma - United States, 1980-2004. Retrieved on 22 May 2008.
http://www.cdc.gov/mmwr/preview/mmwrhtml/ss5608a1.htm.
(8.) Centers for Disease Control and Prevention. National Center for
Health Statistics. Asthma Prevalence, Health Care Use and
Mortality: United States, 2003-05. Retrieved on 22 May 2008. http://www.cdc.gov/nchs/products/pubs/pubd/hestats/ashtma03-05/asthma03
-
05.htm. (due to length of URL, please copy and paste into your browser)
(9.) Centers for Disease Control and Prevention. Advance Data from Vital
and Health Statistics. 2005 National Hospital Discharge Survey.
Retrieved on 22 May 2008.
http://www.cdc.gov/nchs/data/ad/ad385.pdf.
(10.) National Heart, Lung, and Blood Institute. National Asthma
Education and Prevention Program. Expert Panel Report 3: Guidelines
for the Diagnosis and Management of Asthma. Full Report 2007.
Retrieved on 22 May 2008.
http://www.nhlbi.nih.gov/guidelines/asthma/asthgdln.pdf.
(11.) National Institutes of Health. Morbidity & Mortality: 2007 Chart
Book on Cardiovascular, Lung, and Blood Diseases. Retrieved on 22
May 2008. http://www.nhlbi.nih.gov/resources/docs/07-chtbk.pdf.
(12.) Symbicort Prescribing Information.
SOURCE AstraZeneca
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Related links:
http://www.astrazeneca-us.com/
http://www.prnewswire.com/comp/985887.html/
CONTACT:
Michele Meeker, +1-302-885-6351,
michele.meeker@astrazeneca.com, or Katie Neff, +1-302-885-9960,
katie.neff@astrazeneca.com, both of AstraZeneca
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