JCR Pharmaceuticals receives orphan drug designation in Japan for givinostat
The company said it will submit a marketing authorization application for givinostat in Japan by end-2026.
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Jcr Pharmaceuticals Receives Orphan Drug Designation For Givinostat In Japan
JCR Pharmaceuticals Co., Ltd. TSE:4552
JCR Pharmaceuticals gets Japan orphan drug designation for givinostat
Japan's health ministry granted orphan drug designation to givinostat for Duchenne muscular dystrophy. JCR said it is advancing development in Japan and plans to submit a marketing authorization application by end-2026.
JCR Pharmaceuticals Receives Orphan Drug Designation from the Ministry of Health, Labour and Welfare of Japan for Givinostat for Duchenne Muscular Dystrophy
JCR Pharmaceuticals Co., Ltd. (TSE 4552; “JCR”) today announced that the Ministry of Health, Labour and Welfare of Japan granted orphan drug designation to givinostat, an investigational drug for the treatment of Duchenne muscular dystrophy (DMD).Givinostat (marketed as Duvyzat® in the US, EU, and…