Kyowa seeking Japanese approval of pegfilgrastim

Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151) submitted a regulatory application to Japan's Ministry of Health, Labor and Welfare (MHLW) for pegfilgrastim ( KRN125) to treat chemotherapy-induced febrile neutropenia. Kyowa has Japanese rights to the pegylated G-CSF from partner Amgen Inc. (NASDAQ:AMGN). The neutropenia drug is approved in 105 countries and regions including the U.S. and EU, where Amgen markets the drug as Neulasta (see BioCentury, March 18). ...