Press Release

Domestic New Drug Application (NDA) Approval for REGROTH® Dental Kit (600µg & 1200µg)September 28, 2016

Tokyo, September 28, 2016 - Kaken Pharmaceutical Co., Ltd. (“Kaken”) announced it has acquired regulatory approval for the manufacturing and sale of REGROTH® Dental Kit (600µg & 1200µg), a medicinal product for periodontal regeneration [generic name: Trafermin (genetical recombination); hereinafter “REGROTH®”], owing to its efficacy in treating periodontitis which destroys the alveolar bone.

REGROTH® is the world's first pharmaceutical developed for the purpose of periodontal regeneration. The recombinant human bFGF (basic fibroblast growth factor) is the main active ingredient.
Periodontitis is a set of chronic inflammatory diseases caused by plaque and tartar between the teeth and gums. As it progresses, periodontitis gradually destroys the periodontal tissue that supports the teeth. Left untreated, it can ultimately result in tooth loss. A surgery known as a flap operation is sometimes performed to prevent periodontal tissue destruction in advanced cases.

Kaken conducted several clinical trials in Japan involving nearly 1,000 periodontal patients that were to undergo a flap operation. Trial results showed that the application of REGROTH® to the destroyed alveolar bone demonstrated positive results in both effectively and safely regenerating periodontal tissue, including an increase in the alveolar bone height. Kaken submitted the new drug application in October 2015.
Kaken aims to help improve the quality of life for more patients by providing a new treatment option, medicinal product for periodontal regeneration.

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