MHLW Approves Symbicort Turbuhaler

Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved AstraZeneca’s Symbicort Turbuhaler (budesonide/formoterol) for the maintenance treatment of bronchial asthma in patients aged 16 and over when a combination therapy of an inhaled steroid and a long-acting beta-2 agonist is necessary.

Reportedly, AstraZeneca and Astellas Pharma have signed an agreement to co-promote Symbicort Turbuhaler in August 2009. The product is expected to be manufactured and developed by AstraZeneca and distributed and sold by Astellas, while promotion will be jointly carried out by both companies.

AstraZeneca has conducted eight pivotal studies in Japan to support the approval of Symbicort Turbuhaler. These included four studies on formoterol, and four on Symbicort.

Bruno Angelici, executive vice president for international sales and marketing at AstraZeneca, said: “The approval of Symbicort Turbuhaler in Japan will provide patients and physicians with a new treatment option for the approximately five million adults living with asthma in Japan. We are pleased this addition will support our commitment to deliver new medicines in Asia/Japan, working with our long-term partner Astellas.”