Tokyo, Japan, October 16, 2009 - AstraZeneca K.K. (headquarters: Tokyo; President and CEO: Masuhiro Kato) today announced that it received a Japanese manufacturing and marketing approval for Symbicort® Turbuhaler® 30 doses and Symbicort® Turbuhaler® 60 doses for the treatment of adult bronchial asthma. The product will be manufactured and developed by AstraZeneca K.K. and distributed and sold by Astellas Pharma Inc., while promotion will be jointly carried out by both companies (co-promotion).
SymbicortTurbuhaler is a twice-daily treatment for adult bronchial asthma combining budesonide, an inhaled corticosteroid (one dose containing 160μg) and formoterol fumarate dihydrate, a rapid and long acting β2 agonist (one dose containing 4.5μg), and the product is administered by an inhaler (Turbuhaler).
Characteristics of SymbicortTurbuhaler are as follows:
-The Product alone shows good efficacy in countering both of the causes of bronchial asthma, airway inflammation and airway narrowing
- By administering two medications in one product, in addition to the convenience for controlling bronchial asthma, due to the fast onset of bronchial dilation effect of formoterol, patients can easily feel the effect of the treatment. As a result, improvement in adherence (continuation of treatment) can be expected.
The results of Phase III study in Japan show that in Japanese adult bronchial asthma patients SymbicortTurbuhaler shows clinical usefulness compared to combination therapy of budesonide and theophylline sustained release. In terms of safety profile both treatment groups show favorable tolerance. Further, it has been reported that a long-term (52 weeks) study demonstrated favorable tolerance and efficacy.