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DE AstraZ FDA Asthma
(U.S. Newswire Via Acquire Media NewsEdge) BC-DE-AstraZ-FDA-Asthma
To: MEDICAL EDITORS
Contact: Dana Settembrino of AstraZeneca Pharmaceuticals LP, +1-
302-885-6980
WILMINGTON, Del., March 11 /PRNewswire-FirstCall/ -- On March 10-11, 2010,
the Joint Advisory Committees of the U.S. Food and Drug Administration (FDA)
-- including the Pulmonary-Allergy Drugs and the Drug Safety and Risk
Management Advisory Committees -- discussed the design of post-marketing
safety studies for long-acting beta-agonist (LABA)-containing products in the
U.S., including SYMBICORT((R) )(budesonide/formoterol fumarate dihydrate).
(Logo: http://www.newscom.com/cgi-bin/prnh/20091027/PH99766LOGO )
"As we've witnessed over the past two days, there are many challenges in
designing and executing a relevant, feasible and ethical post-marketing safety
study that answers FDA's question regarding LABA-containing products," said
Howard Hutchinson, M.D., Chief Medical Officer of AstraZeneca. "AstraZeneca
(NYSE: AZN) is confident in the positive benefit-risk profile of SYMBICORT in
asthma as demonstrated by extensive clinical data and patient experience, and
supports ongoing scientific discussion to address any outstanding questions
regarding the use of combination LABA and inhaled corticosteroid products for
the treatment of asthma. We look forward to working with the FDA to execute a
study design that is both scientifically robust and offers a pragmatic
approach to answer critical questions regarding the appropriate use of LABAs."
The FDA frequently convenes advisory committee meetings to obtain
independent expert guidance and recommendations on clinical matters. While
the FDA is not required to follow this guidance, the agency usually takes the
advice into consideration when rendering decisions on public health matters.
About SYMBICORT
SYMBICORT is 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 respiratory medications --
budesonide, an inhaled corticosteroid (ICS), and formoterol, a rapid and
long-acting beta2-agonist (LABA). It offers patients with asthma effective
symptom control with the added benefit of rapid improvement in lung function
within fifteen minutes of every dose.( )
SYMBICORT 160/4.5 mcg is also indicated for the maintenance treatment of
airflow obstruction in patients with chronic obstructive pulmonary disease
(COPD), including chronic bronchitis and emphysema. For patients with COPD,
the approved dosage of SYMBICORT is 160/4.5 mcg two inhalations twice daily.(
)SYMBICORT does not replace fast-acting inhalers and should not be used to
treat acute symptoms of COPD or asthma. SYMBICORT should not be initiated in
patients during rapidly deteriorating or potentially life-threatening episodes
of COPD.
For more information about SYMBICORT, please visit http://www.MySYMBICORT.com.
Important Safety Information, including boxed WARNING
WARNING: Long-acting beta2-adrenergic agonists may increase the risk of
asthma-related death. SYMBICORT should only be used for patients with asthma
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 US study that 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 (see WARNINGS in full Prescribing Information).
SYMBICORT is NOT a rescue medication and does NOT replace fast-acting
inhalers to treat acute symptoms.
Particular care is needed for patients who are transferred from
systemically active corticosteroids to inhaled 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 should not use additional formoterol
or other long-acting inhaled beta2-agonists for any reason.
Caution should be exercised when considering the coadministration of
SYMBICORT with long-term ketoconazole and other known potent CYP3A4
inhibitors.
Excessive beta-adrenergic stimulation has been associated with central
nervous system and cardiovascular effects. SYMBICORT, like all products
containing sympathomimetic amines, should be used with caution in patients
with cardiovascular disorders, especially coronary insufficiency, cardiac
arrhythmias, and hypertension.
Long-term use of orally inhaled corticosteroids, such as budesonide, a
component of SYMBICORT, may affect normal bone metabolism resulting in a loss
of bone mineral density.
Glaucoma, increased intraocular pressure, and cataracts have been reported
following the inhaled administration of corticosteroids, including budesonide,
a component of SYMBICORT.
SYMBICORT should be administered with caution to patients being treated
with MAO inhibitors or tricyclic antidepressants, or within 2 weeks of
discontinuation of such agents.
Additional Information Specific to Asthma
The most common adverse events greater than or equal to 5% reported in
clinical trials included nasopharyngitis, headache, upper respiratory tract
infection, pharyngolaryngeal pain, sinusitis, and stomach discomfort.
Additional Information Specific to COPD
For patients with COPD, the approved dosage of SYMBICORT is 160/4.5 mcg, 2
inhalations twice daily.
The most common adverse events greater than or equal to 3% reported in
COPD clinical trials included nasopharyngitis, oral candidiasis, bronchitis,
sinusitis, and upper respiratory tract infection.
Lower respiratory tract infections, including pneumonia, have been
reported following the inhaled administration of corticosteroids.
In 2 placebo-controlled SYMBICORT COPD clinical studies, pneumonia did not
occur with greater incidence in the SYMBICORT 160/4.5 group, compared with
placebo, while the incidence of lung infections other than pneumonia (e.g.,
bronchitis) was higher for SYMBICORT than placebo.
Please see full Prescribing Information, including boxed WARNING, and
visit http://www.MySYMBICORT.com.
About AstraZeneca
AstraZeneca is engaged in the research, development, manufacturing and
marketing of meaningful prescription medicines and in the supply of healthcare
services. AstraZeneca is one of the world's leading pharmaceutical companies
with global healthcare sales of $31.6 billion and is a leader in
gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and
infectious disease medicines. In the United States, AstraZeneca is a $13.5
billion dollar healthcare business.
For more information about AstraZeneca in the US or our AZ&Me(TM)
Prescription Savings programs, please visit: http://www.astrazeneca-us.com.
SOURCE AstraZeneca
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(c) 2010 U.S. Newswire Corp.
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