FDA Approves Symbicort for Chronic Obstructive Pulmonary Disease (COPD)

FDA Approves Symbicort for Chronic Obstructive Pulmonary Disease (COPD)

WILMINGTON, Del. February 27, 2009 /PRNewswire-FirstCall/ -- AstraZeneca today announced that the U.S. Food and Drug Administration (FDA) has approved Symbicort (budesonide/formoterol fumarate dihydrate) 160/4.5 mcg for the twice daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.(2) The FDA approval is based on results from two pivotal clinical trials, SHINE (6-month) and SUN (12-month),(2) which found Symbicort significantly improved lung function within five minutes of the first dose(1) and sustained that lung function improvement for the duration of the studies.(3) Symbicort pMDI (pressurized metered-dose inhaler) has been available in the U.S. since June 2007 for the long-term maintenance treatment of asthma in patients 12 years of age and older.(2)

"More than 12 million Americans with COPD struggle each day to live with the debilitating symptoms of COPD,"(4) said Dr. Howard Hutchinson, Chief Medical Officer, AstraZeneca. "With the approval of Symbicort in COPD, patients have a new treatment option that can deliver lung function improvement(3) and daily symptom control, together with a rapid onset of action."(5)

COPD is the fourth leading cause of death in the nation.(4) Along with the 12 million Americans who suffer from this disease, some estimate that there are an equal amount of people who have COPD but remain undiagnosed.(4) COPD is a disorder encompassing two serious lung diseases - emphysema and chronic bronchitis(4) -- which result in chronic airway inflammation(4) and progressive loss of lung function, making it difficult to breathe normally.(4,6)

The FDA approval is based on two pivotal (Phase III) efficacy and safety trials, SHINE and SUN, which evaluated more than 3,600 patients ages 40 years and older with moderate to very severe COPD. (2) These studies demonstrated that patients using Symbicort pMDI 160/4.5 mcg had significantly greater mean improvements from baseline in pre-dose forced expiratory volume in one second (FEV1) averaged over the treatment period compared with formoterol 4.5 mcg and placebo.(2)

In addition, patients using Symbicort had significantly greater mean improvements from baseline in 1-hour post-dose FEV1 averaged over the treatment period compared with budesonide 160 mcg and placebo.(2) Furthermore, the median time to onset of significant bronchodilation (greater than or equal to 15% improvement in FEV1) was fiveminutes.(1)

Symbicort was generally well-tolerated over the 12-month study,(2) and the incidence of pneumonia was no different for Symbicort compared to placebo.(2) There was a higher incidence of potential lung infections other than pneumonia (e.g., bronchitis and viral lower respiratory tract infections) in patients receiving Symbicort 160/4.5 mcg than in those receiving formoterol 4.5 mcg or placebo.(2) The most common drug-related adverse events reported were nasopharyngitis (the common cold), oral candidiasis, bronchitis, sinusitis and viral upper respiratory tract infection.(2)

"Through these pivotal studies, Symbicort demonstrated rapid and sustained improvements in lung function and was generally well-tolerated long-term for patients with moderate to severe COPD,"(2) said lead investigator Dr. Donald Tashkin of the (). "Healthcare professionals and patients with severe COPD can now consider using Symbicort as a treatment option to manage their symptoms and help control the disease over time."

In patients with severe to very severe COPD, the Global Initiative for Chronic Obstructive Lung Disease (GOLD) recommends the addition of inhaled corticosteroids (ICS) to long-acting beta2-agonists (LABA), in addition to other treatment options.(6) Common symptoms of COPD include shortness of breath, chronic cough, wheezing and excess mucus.(4) 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.(4) As the disease progresses, people with COPD may eventually require long-term oxygen therapy.(6)

Symbicort 160/4.5 mcg is indicated for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.(2) For patients with COPD, the approved dosage of Symbicort is 160/4.5 mcg two inhalations twice daily. Symbicort is also indicated for the long-term maintenance treatment of asthma in patients 12 years of age and older.(2) Administered twice daily,(2) Symbicort is a combination of two proven respiratory medications - budesonide, an inhaled corticosteroid (ICS), and formoterol, a rapid and long-acting beta2-agonist (LABA).(2) Symbicort does not replace fast-acting inhalers and should not be used to treat acute symptoms of COPD or asthma.(2)

Lower respiratory tract infections, including pneumonia, have been reported following the inhaled administration of corticosteroids. In two 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.

Symbicort is not a rescue medication and does not replace fast-acting inhalers to treat acute symptoms.

Symbicort should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of asthma or COPD.

Patients who are receiving Symbicort should not use additional formoterol or other long-acting inhaled beta2-agonists for any reason.

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. Some patients may experience an increase in blood pressure or heart rate.

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.

Common adverse events reported in asthma clinical trials, occurring in greater than or equal to 5% of patients, included nasopharyngitis, headache, upper respiratory tract infection, pharyngolaryngeal pain, sinusitis, and stomach discomfort.

Particular care is needed for patients being transferred from systemically active corticosteroids to inhaled corticosteroids.

Please see full Prescribing Information, including boxed WARNING, and visit www.MySymbicort.com.

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.

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Posted: February 2009

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Symbicort (budesonide and formoterol) FDA Approval History

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