Pentasa Tablets 250 Received Approvals For Additional Pediatric Indication
March 3, 2008
Nisshin Kyorin Pharmaceutical Co., Ltd. that had approval for manufacturing and marketing of Pentasa acquired pediatric indication for Pentasa® Tablets 250 (generic name: mesalazine) on February 29.
Pentasa is a therapy for ulcerative colitis and Crohn's disease that is currently distributed by Kyorin Pharmaceutical Co., Ltd. (Tokyo; President: Ikuo Ogihara), subsidiaries of Kyorin Co., Ltd. and Nisshin Kyorin Pharmaceutical Co., Ltd. (Tokyo; President: Takashi Matsuda) Nisshin Kyorin Pharmaceuticals Co., Ltd. conducted clinical trials in Japan for the drug developed by Ferring (Switzerland).
Pentasa was designated as an orphan drug in November 1993 and was approved for manufacturing and marketing as an agent for ulcerative colitis and Crohn's disease in April 1996. Kyorin Pharmaceutical Co., Ltd. and Nisshin Kyorin Pharmaceutical Co., Ltd. marketed the drug in July 1996. Since then, the companies have contributed to the treatment of ulcerative colitis and Crohn's disease. Approval for pediatric indication will further satisfy the need for treatment of inflammatory bowel diseases.
Inflammatory bowel diseases (ulcerative colitis and Crohn's disease) are intractable diseases that hinder social interaction, causing frequent diarrhea and melena. The causes have not been identified and there is no basic remedy. Therefore, therapeutic goals are suppressing symptoms in the active phase, alleviating the symptoms and keeping the symptoms in the relieved state with the use of Pentasa and other mesalazine drugs and steroids. In addition, it has been hoped that added indications in pediatrics would be provided because inflammatory bowel diseases occur even in childhood, affecting children's growth and learning.
Pentasa has extensive use experience in other countries: the indication for the drug for ulcerative colitis in adults has already been approved in 43 countries, and for Crohn's disease in 39 countries, and the indication for inflammatory bowel diseases in infants has been approved in 20 countries.
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