Approval for Sustained-Duration G-CSF Product G-Lasta in Japan

On September 26, 2014 Kyowa Hakko Kirin reported that it has received approval for sustained-duration G-CSF product G-Lasta subcutaneous injection 3.6mg (G-Lasta) [generic name: pegfilgrastim (genetical recombination)] by the Ministry of Health, Labour and Welfare (MHLW) (Press release Kyowa Hakko Kirin, SEP 26, 2014, View Source [SID:1234500782]).

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G-Lasta is a sustained duration form of Granulocyte Colony-Stimulating Factor (G-CSF) product, which is produced by PEGylation of filgrastim, for treatment of chemotherapy-induced neutropenia. While filgrastim requires repeated daily doses over several days, G-Lasta shows comparable efficacy with a single dose per chemotherapy cycle. G-Lasta is therefore expected to reduce the burden of drug administration and to decrease frequent hospital visits of outpatients undergoing chemotherapy. Also, prophylactic administration of G-Lasta prior to neutropenia is expected to reduce risks of infection, which results in clinical benefits such as improving the compliance with doses and schedules of chemotherapy.

Pegfilgrastim, originally generated by Amgen, Inc., was licensed from Kirin-Amgen Inc., to Kyowa Hakko Kirin. It has already been approved in 107 countries and regions around the world.