US FDA approves Symbicort (budesonide/formoterol) for the treatment of asthma in paediatric patients

30 January 2017

AstraZeneca today announced that the US Food and Drug Administration (FDA) approved Symbicort® (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol 80/4.5 micrograms for the treatment of asthma in paediatric patients aged six up to 12 years.1 Budesonide/formoterol is already approved in the US to treat asthma in patients 12 years and older and for the maintenance treatment of airflow obstruction in Chronic Obstructive Pulmonary Disease (COPD) in adults.

The FDA approval is based on the CHASE (ChildHood Asthma Safety and Efficacy) clinical trial programme, which included the CHASE 3 Phase III trial. This trial demonstrated budesonide/formoterol 80/4.5 micrograms delivered in a pressurised metered-dose inhaler (pMDI) significantly improved lung function in paediatric patients with asthma aged six up to 12 years who were symptomatic on low-dose inhaled corticosteroid versus budesonide pMDI 80 micrograms, both delivered as two inhalations twice daily.The safety profile in paediatric patients aged six up to 12 years is similar to the safety profile in patients aged 12 years and older.1,3

“We are pleased to now be able to also offer Symbicort to younger patients in the US, starting at six years of age, helping to control and prevent asthma symptoms,” said Kai Richter, Vice President Respiratory Medical Affairs, AstraZeneca. “Symbicort continues to be a cornerstone of asthma care around the world and it remains a key medicine in our growing respiratory portfolio.”

With this expanded indication, budesonide/formoterol can now be used to treat a wider range of US patients suffering from asthma. Budesonide/formoterol is an ICS/LABA (inhaled corticosteroid/long-acting beta2-agonist bronchodilator) controller medication that has been shown to help control asthma by reducing inflammation in the lungs and keeping airways open. It is not indicated in the US for the relief of acute bronchospasm. Outside of the US, budesonide/formoterol has been approved for use in over 100 countries for the regular treatment of asthma, where use of a combination (ICS and LABA) is appropriate, either as Symbicort Turbuhaler or as Symbicort pMDI, and in the majority of countries it is approved from 6 years and above. In most countries, Symbicort Turbuhaler has also been approved as Symbicort Maintenance And Reliever Therapy (SMART) for asthma in adults and in adolescent or younger patients in a number of these countries. In addition, Symbicort has been approved in 88 countries for the symptomatic treatment of COPD in adults with moderate/severe airflow obstruction and a history of exacerbations despite regular bronchodilator therapy.

An estimated 6.3 million children under the age of 18 years in the US have been diagnosed with asthma.4 If left untreated, they often have to avoid physical activities to prevent symptoms, such as coughing or wheezing, and absence from school is common.5,6



About Asthma

Asthma is the most common chronic respiratory disease and it affects the health and day-to-day lives of more than 300 million adults and children worldwide.7 It is characterised by recurrent breathlessness and wheezing, which vary in severity and frequency from person to person.8,9

About Symbicort

Symbicort is a combination formulation containing budesonide, an inhaled corticosteroid (ICS), and formoterol, a long-acting beta2-agonist bronchodilator (LABA), in a single inhaler. Budesonide/formoterol was first launched in Sweden in 2000 and has been approved in approximately 120 countries to treat asthma and/or COPD either as Symbicort Turbuhaler or Symbicort pMDI (pressurised metered-dose inhaler).

About AstraZeneca in Respiratory Disease

Respiratory disease is one of AstraZeneca’s main therapy areas, and we have a growing portfolio of medicines that reached more than 17 million patients in 2015. Our aim is to transform asthma and COPD treatment through inhaled combinations at the core of care, biologics for the unmet needs of specific patient populations, and scientific advancements in disease modification. We are building on a 40-year heritage in respiratory disease, and our capability in inhalation technology spans both pressurised metered-dose inhalers (pMDIs) and dry powder inhalers (DPIs), as well as our innovative Co-SuspensionTM Delivery Technology. Our research is focused on four key biological pathways: eosinophilic disease, Th2-driven disease, epithelial-driven pathobiology and autoimmunity.

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three main therapy areas - Oncology, Cardiovascular & Metabolic Diseases and Respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit and follow us on Twitter @AstraZeneca.



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  1. Symbicort Prescribing Information. AstraZeneca Pharmaceuticals LP
  2. Pearlman, David, et al. Efficacy of Budesonide/Formoterol Pressurized Metered-dose Inhaler Versus Budesonide Alone in Children (6-<12 years) With Asthma. Abstract at ACAAI Meeting, 10-14 November 2016. Available at: Last accessed January 2017.
  3. Lanz, Miguel et al. Safety of Budesonide/Formoterol Pressurized Metered-dose Inhaler Versus Budesonide in Children (6-<12 years) With Asthma. CHASE Safety ACAAI 2016 Abstract, 19 July 2016.
  4. Centers for Disease Control and Prevention. Asthma. Available at: Last accessed January 2017.
  5.  American Academy of Allergy Asthma & Immunology. Childhood Asthma. Available at: Last accessed January 2017.
  6. Akinbami, LJ, Moorman, JE, Liu, X. Asthma prevalence, healthcare use, and mortality: United States, 2005–2009. National health statistics report; no 32. Hyattsville, MD: National Center for Health Statistics. 2011. Accessed January 2017.
  7. Masoli M, Fabian D, Holt S, Beasley R, for the Global Initiative for Asthma (GINA) Program. The global burden of asthma: executive summary of the GINA Dissemination Committee Report. Allergy 2004: 59: 469–478.
  8. NHS Choices. Asthma: introduction. Available at: Last accessed January 2017.
  9. NHS Choices. Symptoms of asthma. Available at: Last accessed January 2017.