Additional Approvals for Bisono^® Tape, a Transdermal Patch containing a β₁ Blocker, for Atrial Fibrillation, for a 2 mg strength and for improved formulations of 4 mg and 8 mg strengths in Japan

Tokyo: January 8, 2019 - Toa Eiyo Ltd. (President: Atsuo Takahashi, Ph.D., “Toa Eiyo”) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D.) announced today that Toa Eiyo received approvals for Bisono^® Tape 2 mg, Bisono^® Tape 4 mg and Bisono^® Tape 8 mg (collectively, “Bisono^® Tape”, non-proprietary name: bisoprolol), transdermal patches containing a β₁ blocker, in Japan for the new indication of atrial fibrillation. These approvals cover a marketing approval for the new 2 mg strength intended for therapeutic dose reduction, as well as approvals for improved formulations of Bisono^® Tape 4 mg and Bisono^® Tape 8 mg to achieve functional improvements including water resistance.

　Bisono^® Tape was co-developed by Toa Eiyo and Nitto Denko Corporation (TSE: 6988, President and CEO: Hideo Takasaki, “Nitto”). Bisono^® Tape 4 mg and Bisono^® Tape 8 mg were launched in September, 2013 in Japan as the world’s first transdermal medication for essential hypertension (mild to moderate cases) containing 4 mg and 8 mg of bisoprolol, a β₁ blocking agent, respectively. 

　Since Bisono^® Tape has been expected to show clinically significant efficacy for the control of heart rate in patients suffering from atrial fibrillation as based on recommendation in a pharmacotherapy guideline* for administration of the β blocking agent as well as to ease the treatment of patients with swallowing difficulties, the development was conducted to obtain approval for this new indication of atrial fibrillation. Furthermore, to realize a therapeutic dose reduction, a new strength, Bisono^® Tape 2 mg, was co-developed by Toa Eiyo and Nitto. The Bisono^® Tape 2 mg will be launched following listing in the National Health Insurance drug price list in Japan.

　Moreover, the formulations for Bisono^® Tape 4 mg and Bisono^® Tape 8 mg were improved to increase water resistence and to prevent reduction of adhesiveness due to reasons such as sweating at the site of application. 

　These additional approvals will provide new treatment options for patients suffering from essential hypertension or atrial fibrillation, who have difficulties in swallowing oral medication, and are expected to contribute to improvement in medication adherence and thereby supporting treatment continuation for this group of patients.