WILMINGTON, Del., April 30 /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 treatment of patients with Chronic Obstructive
Pulmonary Disease (COPD). SYMBICORT is currently approved for the long-term
maintenance treatment of asthma in patients 12 years and older.
"COPD is a serious, debilitating lung disease affecting 12 million
Americans,(1)" said lead investigator Dr. Donald Tashkin of the University
of California, Los Angeles (UCLA). "If SYMBICORT receives approval from the
FDA to help manage COPD, it could offer the millions of people living with
this disease a new treatment option."
The sNDA submission is based on results from two pivotal efficacy and
safety trials, SHINE and SUN, with SYMBICORT pressurized metered dose
inhaler (pMDI).(2),(3) Of note, both trials showed a safety profile
consistent with the established profiles for this product and its
mono-components.(2),(3) The most common adverse events found in these
trials were bronchitis, oral candidiasis, viral upper respiratory tract
infection and nasopharyngitis, also known as the common cold.(2),(3)
SHINE Study Results
-- 6-month randomized, double-blind, parallel-group, multi-center trial of
patients (N=1,704) with moderate to very severe COPD.(3)
-- SYMBICORT 160/4.5 micrograms (mcg) two puffs twice a day demonstrated a
statistically significantly greater increase from baseline in average
pre-dose FEV1 compared with formoterol 4.5 and in average post-dose
FEV1 compared with budesonide 160, with maintenance of effect for both
comparisons over the 6-month treatment period.(3)
-- SYMBICORT pMDI 160/4.5 also demonstrated a significant increase from
baseline for the average post-dose FEV1 compared with formoterol
4.5.(3)
SUN Study Results
-- 12-month randomized, double-blind, parallel-group, multi-center trial
of patients (N=1,964) with moderate to very severe COPD.(2)
-- SYMBICORT 160/4.5 mcg two puffs twice a day (320/9 mcg) met the
pre-specified co-primary endpoints.(2)
-- SYMBICORT demonstrated a statistically significantly greater increase
from baseline in pre-dose FEV1 and 1-hour post-dose FEV1 compared with
formoterol and placebo.(2)
-- Results showed an overall maintenance effect over the 12-month
treatment period in patients with moderate to very severe COPD.(2)
"SYMBICORT is a combination maintenance treatment for patients with
asthma that works rapidly to help improve lung function by reducing
inflammation in the lining of the lung, (4),(8)" said Howard Hutchison,
Chief Medical Officer, AstraZeneca. "We are confident in the data from the
SHINE and SUN trials that support our submission, and we look forward to
discussions with the FDA about this potential expanded indication."
About COPD
More than 12 million people in the United States suffer from COPD, and
it is the fourth leading cause of death in the nation.(1) Some estimates
also suggest that 12 million more people have COPD but are undiagnosed.(1)
COPD is a term referring to two serious lung diseases -- emphysema and
chronic bronchitis -- that cause a person's airways to become inflamed over
time, making it difficult to breathe normally.(1) Common symptoms include
shortness of breath, chronic cough, wheezing and excess mucus.(1) For
patients with moderate to very severe COPD, to reduce exacerbations and
improve lung function and health status, the Global Initiative for Chronic
Obstructive Lung Disease (GOLD) recommends the use of combination
treatments with an inhaled corticosteroid (ICS) and long-acting
beta2-agonist (LABA), in addition to other treatment options.(6) COPD is a
progressive disease, which means people with COPD can expect lung function
to worsen over time.(6) When symptoms are severe, it can be difficult for a
person to perform simple, daily tasks.(1) As the disease progresses, people
with COPD may eventually require supplemental oxygen and may have to rely
on mechanical ventilatory assistance.(7)
About SYMBICORT
SYMBICORT is a combination therapy indicated for the long-term
maintenance treatment of asthma in patients 12 years of age and older.(4)
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).(4) SYMBICORT does not replace
fast-acting inhalers and should not be used to treat acute symptoms of
asthma.(4)
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) COPD Learn More Breathe Better. National Heart Lung and Blood
Institute. Retrieved on 21 Mar 2008.
http://www.nhlbi.nih.gov/health/public/lung/copd/index.htm.
(2) Rennard, Stephen I., et al. A 12-Month Double-Blind, Double-Dummy,
Randomized, Parallel Group, Multicenter Efficacy & Safety Study of
SYMBICORT(R) pMDI 2 x 160/4.5 microgram bid and Placebo in Patients
with COPD. [CLINICAL STUDY REPORT].
(3) Tashkin, Donald P., et al. A 6-Month Double-Blind, Double-Dummy,
Randomized, Parallel Group, Multicenter Efficacy & Safety Study of
SYMBICORT(R) pMDI 2 x 160/4.5 microgram & 80/4.5 microgram bid
Compared to Formoterol TBH, Budesonide pMDI (& the combination) &
Placebo in COPD Patients. [CLINICAL STUDY REPORT].
(4) Symbicort Prescribing Information.
(5) How is COPD Treated? National Heart Lung and Blood Institute.
Retrieved on 21 Mar 2008.
http://www.nhlbi.nih.gov/health/dci/Diseases/Copd/Copd_Treatments.html.
(6) Pocket Guide to COPD Diagnosis, Management, and Prevention. Global
Initiative for Chronic Obstructive Lung Disease. Retrieved on 1 Apr
2008. http://goldcopd.com/Guidelineitem.asp?l1=2&l2=1&intId=1116.
(7) Global Strategy for the Diagnosis, Management, and Prevention of
Chronic Obstructive Pulmonary Disease, 2007. Retrieved on 21 Apr 2008.
http://www.goldcopd.com/Guidelineitem.asp?l1=2&l2=1&intId=996.
(8) Asthma and Allergy Foundation of American. Asthma Medications.
Available at http://www.aafa.org/display.cfm?id=8&sub=16&cont=42.
Accessed on 4/25/08.
SOURCE AstraZeneca
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Related links:
http://www.astrazeneca-us.com
http://www.mysymbicort.com
http://www.prnewswire.com/comp/985887.html /
CONTACT:
Michele Meeker, +1-302-885-6351,
michele.meeker@astrazeneca.com; Katie Neff, +1-302-885-9960,
katie.neff@astrazeneca.com, both of AstraZeneca
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