Symbicort, which is already approved in Europe, is a twice-daily asthma therapy combining budesonide, an inhaled corticosteroid, and formoterol, a rapid and long-acting beta2-agonist into one inhaler. AstraZeneca said it plans to launch Symbicort in the US in mid 2007.
This kind of combination therapy, specifically adding long-acting inhaled beta-agonists to inhaled corticosteroids for long-term control and prevention of symptoms in moderate and severe-persistent asthma is recommended by the National Asthma Education and Prevention Program (NAEPP) of The National Institutes of Health (NIH).
The approved indication is based on data from two pivotal double blind, placebo-controlled, 12-week trials involving 1,076 patients in the US, age 12 and over. These studies showed that both dosage strengths of Symbicort produced a greater improvement in lung function compared to the same doses of budesonide or formoterol administered alone or placebo.
“We are very pleased that the FDA has approved Symbicort in the US,” said David Brennan, CEO, AstraZeneca. “Millions of Americans suffer from asthma and the availability of Symbicort affords them a new opportunity to achieve better asthma control.”