AstraZeneca responds to FDA advisory committees' recommendation on SYMBICORT

On December 11, 2008, the Joint Advisory Committees of the U.S. Food and Drug Administration (FDA) - including the Drug Safety & Risk Management Advisory Committee, the Pediatric Advisory Committee, and the Pulmonary-Allergy Drugs Advisory Committee - completed a review of the benefits and risks of asthma medications containing long-acting beta-agonists (LABAs).

The committees concluded that the benefits of AstraZeneca's SYMBICORT(R) (budesonide/formoterol fumarate dihydrate), a combination LABA/Inhaled Corticosteroid (ICS) medication, outweigh the risks in adult and adolescent asthma patients.

Howard Hutchinson, M.D., Chief Medical Officer of AstraZeneca, said, "The safety and efficacy of SYMBICORT have been demonstrated in numerous clinical trials and from extensive post-marketing use around the world. We are pleased that the joint advisory committees' recommendation confirms our view on the positive benefit-risk profile of SYMBICORT."

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 its final decisions on pending applications and other public health matters.

About SYMBICORT in the U.S.

SYMBICORT(R) (budesonide/formoterol fumarate dihydrate) is approved in over 100 countries for the long-term maintenance treatment of asthma and is available in two different inhalers, SYMBICORT TURBUHALER and in the U.S. as SYMBICORT pMDI.

SYMBICORT is a combination therapy indicated in the U.S. for the long-term maintenance treatment of asthma in patients 12 years of age and older. SYMBICORT should not be used in patients whose asthma can be successfully managed by inhaled corticosteroids along with occasional use of inhaled short-acting beta2-agonists. 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.

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 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.

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 less than or equal to 5 percent of patients, regardless of relationship to treatment, included nasopharyngitis, headache, upper respiratory tract infection, pharyngolaryngeal pain, sinusitis, and stomach discomfort.

http://www.astrazeneca-us.com/

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