AstraZeneca Asthma Drug Symbicort Positive In Safety Trial
Zacks Investment Research | Aug 31, 2016 10:21PM ET
AstraZeneca PLC (NYSE:AZN) announced positive results from a safety study on Symbicort inhaler in patients suffering from asthma compared to budesonide alone.
Symbicort is presently marketed for the treatment of asthma and chronic obstructive pulmonary diseases (COPD).
Results from the safety study showed that Symbicort demonstrated comparable risk of serious asthma-related events and lower risk of asthma exacerbations compared to Pulmicort alone.
Symbicort pressurized metered dose inhaler (pMDI) is a combination of two active therapies – formoterol, a long-acting beta-adrenoceptor agonist (LABA) and budesonide, an inhaled corticosteroid (ICS). The study was conducted as part of FDA’s post marketing requirement. Note that the FDA had instructed all U.S. manufacturers of LABA-containing asthma products, like Symbicort, to conduct studies to determine the safety of a combination of LABAs with an ICS.
The study data establishes the safety of AstraZeneca's ICS/LABA combination therapy.
The study, which began in 2011, has been conducted in 25 countries in asthma patients aged 12 years or above. AstraZeneca is currently discussing the results with the FDA for the agency’s post-marketing requirements.
Symbicort is one of the leading products in AstraZeneca’s respiratory portfolio. Due to persistent generic threat for the product, the company has been focused on a label expansion for Symbicort to boost its sales.
Symbicort is being studied for mild asthma in two phase III studies, with results from both the studies expected next year. AstraZeneca is also developing Symbicort as a breath-actuated inhaler for both asthma and COPD patients. Regulatory filing in the U.S. is slated for 2018.
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