AstraZeneca Submits an sNDA for SYMBICORT® for the Treatment of Asthma in Children as Young as Age Six


AstraZeneca Submits an sNDA for SYMBICORT® for the Treatment of Asthma in
Children as Young as Age Six

AstraZeneca 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® (budesonide/formoterol fumarate dihydrate)
Inhalation Aerosol for the long-term maintenance treatment of asthma in
paediatric 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,” 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. 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. In this study, SYMBICORT
was compared to budesonide pMDI and formoterol dry powder inhaler. A second
study evaluating this dose included 351 subjects ages 6 to 11 years old. Results
from both studies demonstrated that SYMBICORT 80/9 mcg twice daily had a similar
safety profile to one of the mono-components, budesonide; 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. The most common adverse
events reported were headache, pyrexia, upper respiratory tract infection,
nasopharyngitis, and pharyngolaryngeal pain. 

- Ends -

June 4, 2008

About Paediatric 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. Nearly 9 million
children in the U.S have been diagnosed with asthma at some point in their
lives. Asthma is a cause of school absenteeism, accounting for nearly 13 million
missed days of school in 2003. It is also the second leading respiratory disease
to cause hospitalization in children under the age of 15. 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. 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.

About SYMBICORT
SYMBICORT is a combination therapy indicated for the long-term maintenance
treatment of asthma in patients 12 years of age and older. 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). SYMBICORT does not replace fast-acting inhalers and should
not 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 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

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