Tokyo, Japan, August 10, 2012 – Astellas Pharma Inc. (“Astellas”, headquarters: Tokyo; President and CEO: Yoshihiko Hatanaka) and AstraZeneca K.K. (“AstraZeneca”, headquarters: Osaka; Representative Director and President: Paul Hudson) today announced that Symbicort® Turbuhaler® has been approved for the additional indication of chronic obstructive pulmonary disease (COPD).

COPD is a chronic, inflammatory lung disease caused by long-term, regular inhalation of harmful agents contained in tobacco smoke and other substances. The principal symptoms are coughing, sputum, shortness of breath and difficulty in breathing. COPD is the fourth most common cause of death worldwide and the number of potential patients in Japan is estimated to exceed 5.3 million.

Symbicort® Turbuhaler® is a combination product containing a long-acting β2 agonist (LABA) with a bronchodilating action that is the mainstay of drug-based COPD therapy, and an inhaled corticosteroid (ICS), which reduces exacerbations of COPD. Symbicort® Turbuhaler® can reduce exacerbations of COPD and has a rapid onset of action, substantially contributing to an improved quality-of-life (QOL) for COPD patients. 

In the case of COPD patients, Symbicort® Turbuhaler® needs to be inhaled four times per day (twice in the morning and twice at night) from the inhalation device (Turbuhaler®). The daily dose is 640μg of budesonide and 18μg of formoterol fumarate hydrate.

Symbicort® Turbuhaler® was launched in Japan in January 2010 as a twice-daily, dry-power inhaler combination product for the treatment of bronchial asthma. As of April 2012, it is approved as a treatment for asthma in 114 countries and for COPD in 106 countries.

The approval of Symbicort® Turbuhaler® for COPD alongside the existing adult bronchial asthma indication will allow Astellas and AstraZeneca to maximize the value of the product and further promote its appropriate use so as to improve the treatment of COPD in Japan.