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news.Japan-based pharmaceutical company Toyama Chemical and Eisai have decided to withdraw temporarily the new drug application of anti-rheumatic drug T-614, which have been developed jointly by the two companies in Japan.
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The new drug application (NDA) of T-614 was submitted to the Japanese Ministry of Health, Labour and Welfare by the companies on September 24, 2003. Subsequent interviews with the Pharmaceuticals and Medical Devices Agency as well as the recent shift in treatment of rheumatoid arthritis have made the companies decide to conduct an additional study for data on efficacy and safety of T-614 when used as an add-on therapy to the standard treatment.
The companies will proceed with the additional study swiftly, and aim to resubmit the NDA in financial year of 2011.
T-614 is a novel disease-modifying anti-rheumatic drug originally discovered by Toyama Chemical. Through development of this new drug, the companies aim to bring a new treatment option for rheumatoid arthritis.