Dainippon Sumitomo launches Replagel in Japan

Tokyo, Japan-based Dainippon Sumitomo Pharma has launched Replagal (agalsidase-alfa [genetic recombination]) for Anderson-Fabry disease, a lysosomal storage disorder caused by congenitally deficient or reduced activity of a-galactosidase-A, a hydrolytic enzyme present in intracellular lysosomes. Anderson-Fabry disease is a multi-system disorder in which glycosphingolipids, which should normally be broken down, progressively accumulate within cells and tissues as ceramide trihexoside resulting in tissue and organ dysfunction, in particular kidney disease, heart disease and stroke. Licensed for sale in Japan from Shire Human Genetic Therapies, of Cambridge, Massachusetts, USA, Replagal was first approved in the European Union in August 2001 and Japan is the 40th country where clearance has been granted.