FDA AdCom on Symbicort

RNS Number : 0109K

AstraZeneca PLC

12 December 2008

 



ASTRAZENECA RESPONDS TO FDA JOINT ADVISORY COMMITTEES' RECOMMENDATION ON SYMBICORT

On 11 December 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 (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 outside the U.S.

SYMBICORT (budesonide/formoterol fumarate dihydrate) is a combination of two proven medications - budesonide, an inhaled corticosteroid (ICS), and formoterol, a rapid and long-acting beta₂-agonist (LABA). SYMBICORT is approved in over 100 countries for the long-term maintenance treatment of asthma and is available in two different inhalers, SYMBICORT TURBUHALER and SYMBICORT pMDI.  

SYMBICORT TURBUHALER is a combination therapy indicated for the long-term maintenance treatment of paediatric and adult asthma patients who cannot be adequately controlled on other medications such as inhaled corticosteroids. 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. 

SYMBICORT TURBUHALER is also indicated for use in patients with Chronic Obstructive Pulmonary Disease (COPD) in 88 countries.

About AstraZeneca

AstraZeneca is a major international healthcare business engaged in research, development, manufacturing and marketing of prescription pharmaceuticals and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of US $29.55 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection product sales. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.  For more Information visit www.astrazeneca.com

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12 December 2008

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