Therapy Areas: Cardiovascular
FDA Approves Updates to Symbicort Label Following Analysis of Safety Trials
22 December 2017 - - US-based prescription medicines specialist AstraZeneca-US has received US Food and Drug Administration approval of updates to the labeling of Symbicort Inhalation Aerosol, including removal of the boxed warning for serious asthma-related outcomes, the company said.
Symbicort is a combination formulation containing budesonide, an inhaled corticosteroid (ICS), and formoterol, a long-acting beta2-adrenergic agonist (LABA) bronchodilator in a single inhaler.
The required Symbicort study began in 2011 when, to further evaluate the safety of LABAs when used in combination with ICS for the treatment of asthma, the FDA required the manufacturers of LABAs to conduct similar randomized, double-blind, controlled clinical trials comparing the addition of LABAs to ICS versus ICS alone.
The FDA analyzed a total of four clinical trials involving 41,297 patients. The four studies supported the decision to remove the boxed warning for the ICS/LABA class.
Labels of medicines that contain both an ICS and LABA retain a warning and precaution related to the increased risk of asthma-related death when LABAs are used without an ICS to treat asthma.
Respiratory disease is one of AstraZeneca's main therapy areas. The company's 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.
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of diseases in three main therapy areas - oncology, cardiovascular and 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.


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