Kyowa Hakko set to file for pegfilgrastim approval in Japan following strong Ph III data

28 January 2013

Mid-size Japanese drugmaker Kyowa Hakko Kirin (TYO: 4151) on Friday released positive top-line results of two Phase III trials of KRN125 (pegfilgrastim; marketed by Amgen as Neulasta) which is developed to decrease the risk of febrile neutropenia in chemotherapy-received patients.

The studies were conducted with malignant lymphoma patients and breast cancer patients. Each study met its primary endpoints. Based on these above findings, Kyowa Hakko Kirin is planning to file a marketing approval application for KRN125 sometime in 2013 in Japan.

The decision comes soon after Japanese drugmaker Mochida Pharmaceutical (TYO: 4534) received marketing authorization from Japan’s Ministry of Health, Labor and Welfare for filgrastim, which was co-developed by Fuji Pharma, a division of Fujifilm (The Pharma Letter November 26, 2012).

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