Symbicort
AstraZeneca PLC
24 July 2006
AstraZeneca's SYMBICORT(R) (budesonide/formoterol) Treatment For Asthma Approved
By The FDA
AstraZeneca has announced that the U.S. Food and Drug Administration (FDA) has
approved SYMBICORT(R) (budesonide/formoterol) for the maintenance treatment of
asthma in patients age 12 and older.
SYMBICORT is a twice-daily asthma therapy combining budesonide, an inhaled
corticosteroid, and formoterol, a rapid and long-acting beta2-agonist into one
inhaler. SYMBICORT will be available in a pressurized metered dose inhaler
(pMDI), the most commonly used and prescribed delivery device in the U.S.
market. The United States is the first country where SYMBICORT will be
available in this type of device. The FDA has approved two dose strengths for
SYMBICORT, 80/4.5 and 160/4.5 mcg of budesonide and formoterol, respectively.
'We are very pleased that the FDA has approved SYMBICORT in the United States,'
said David Brennan, Chief Executive Officer, AstraZeneca. 'Millions of Americans
suffer from asthma and the availability of SYMBICORT affords them a new
opportunity to achieve better asthma control.'
Combination therapy, specifically adding long-acting inhaled beta-agonists to
inhaled corticosteroids for long-term control and prevention of symptoms in
moderate and severe-persistent asthma is recommended by National Asthma
Education and Prevention Program (NAEPP) of The National Institutes of Health
(NIH).
The SYMBICORT submission was based on 27 Phase I, II, and III trials designed to
assess the efficacy and safety of SYMBICORT in a metered dose inhaler. The
approved indication is based on data from two pivotal double blind,
placebo-controlled, 12-week trials involving 1,076 patients in the United
States, age 12 and over. These studies showed that both dosage strengths of
SYMBICORT produced a greater improvement in lung function compared to the same
doses of budesonide and formoterol administered alone or placebo. In addition,
these studies demonstrated a more rapid improvement in lung function compared to
budesonide and placebo. Significant improvement in lung function occurred within
15 minutes of beginning treatment with Symbicort. SYMBICORT is not indicated
for the relief of acute bronchospasm.
AstraZeneca plans to launch SYMBICORT in the US in mid 2007.
Asthma is a reversible obstructive lung disease caused by increased reaction of
the airways to various stimuli. It is a serious chronic medical condition and
can be life-threatening if not properly managed. In 2002, the Centers for
Disease Control estimated that nearly 20 million Americans had asthma, and
nearly 12 million of these had an attack or episode during the previous year.
Despite the availability of many treatments in the United States to treat adults
with asthma, the disease is still poorly controlled. Studies have shown that
patients experience emergency department (ED) visits, hospitalizations, or
attacks at a steady rate. Additionally, asthma patients who have experienced an
asthma attack are twice as likely to experience additional exacerbations as
other patients. The annual direct healthcare cost of the disease in the US is
approximately $10.1 billion. Indirect costs (e.g., lost productivity due to
missed days at school or work) add another $8.2 billion, for a total cost of
$18.3 billion.
SYMBICORT received European Mutual Recognition for the treatment of asthma in
December 2000 and is currently approved in over 90 countries and has reached
more than 5 million patient years outside the United States.
ABOUT ASTRAZENECA
AstraZeneca is a major international healthcare business engaged in the
research, development, manufacture and marketing of prescription pharmaceuticals
and the supply of healthcare services. It is one of the world's leading
pharmaceutical companies with healthcare sales of $23.95 billion and leading
positions in sales of gastrointestinal, cardiovascular, neuroscience,
respiratory, oncology and infection products. In the United States, AstraZeneca
is a $10.77 billion healthcare business with more than 12,000 employees.
AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as
the FTSE4Good Index.
For more information about AstraZeneca, please visit www.astrazeneca.com
24 July 2006
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