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Japan

Press Release 2019

2019/Jan/08

Additional Approvals for Bisono®Tape, a Transdermal Patch containing a β1Blocker, for Atrial Fibrillation, for a 2 mg strength and for improved formulations of 4 mg and 8 mg strengths in Japan

Nitto Denko Corporation (Head Office: Osaka, Japan; President, CEO & COO: Hideo Takasaki, “Nitto”) announced that on January 8, 2019, Toa Eiyo Ltd.(President: Atsuo Takahashi, Ph.D., “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 β1blocker that were co-developed by the two companies, 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.

Toa Eiyo received approval for Bisono® Tape 4 mg and Bisono® 8 mg in June 2013 and they 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 β1blocking agent, respectively.

Because administration of a β-blocker is indicated*in the guideline for heart rate control treatment for atrial fibrillation, and considering the clinical significance of easier administration for patients who have difficulties with oral administration, Nitto and Toa Eiyo have conducted joint development for additional efficacy for atrial fibrillation. Furthermore, a new strength, Bisono® Tape 2 mg, was developed to realize a therapeutic dose reduction. (Bisono® Tape 2 mg will be launched following listing on 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 resistance 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.

*Group JCSJW. Guidelines for Pharmacotherapy of Atrial Fibrillation (JCS 2013)

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Nitto Denko Corporation
TEL:+81-6-7632-2101
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