Kyowa Hakko Kirin files for KW-3357 approval in Japan

1 August 2014

Japanese drugmaker Kyowa Hakko Kirin (TYO: 4151) has filed an application for marketing approval with the Ministry of Health, Labor and Welfare (MHLW) for its recombinant human antithrombin (AT) preparation (code name KW-3357).

The drug is being developed for thrombophilia due to congenital AT III deficiency (CAD) and disseminated intravascular coagulation (DIC) accompanied by a decrease in AT III.

Kyowa Hakko Kirin conducted the Phase III trials described below in order to confirm the safety and efficacy of KW-3357 in Japan and filed a marketing approval application for the preparation based on the results of those studies.

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