Tokyo, October 1, 2015 – Kaken Pharmaceutical Co., Ltd. (“Kaken”) today announced that it submitted a new drug application for “KDB-1D” [generic name: Trafermin (genetical recombination)], a medicinal product for periodontal regeneration, to the Ministry of Health, Labour and Welfare in Japan.
KCB-1D (active ingredient: recombinant human bFGF) is a topical solution for dentistry. 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. KCB-1D has been shown to regenerate periodontal tissue, such as the alveolar bone, if applied to the region of periodontal tissue defect during a flap operation.
Currently, there is no pharmaceutical product that regenerates periodontal tissue in Japan. KCB-1D would be the first to do so and offer a new therapeutic procedure for periodontitis.