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Latest News on Thrombomodulin — A Therapeutic Agent For Disseminated Intravascular Coagulation
(Tokyo, September 27, 2002) - Mochida Pharmaceutical Co., Ltd. (TSE: 4534, 1st Section) and JCR Pharmaceuticals Co., Ltd. (OSE: 4552, 2nd Section) announced today the decision to withdraw their joint application for approval to manufacture Thrombomodulin (proposed retail name: THRODULIN Inj.), a therapeutic agent for disseminated intravascular coagulation (DIC), and to re-examine the course of future development of the drug, including supplemental studies.
As a result, they announced that the planned launch of the drug, initially scheduled for September 2003, was certain to be delayed.
Although the application for approval to manufacture the drug was submitted in September 2001, comments received in the review process regarding inadequacies in the design of the Phase III study and on the study results themselves are behind this decision.