Amerigen and Dipharma announced that the Food and Drug Administration (FDA) has approved the Abbreviated New Drug Application (ANDA) for Miglustat 100mg Capsules, the first generic version of Actelion’s  Zavesca.

Miglustat, a glucosylceramide synthase inhibitor, is indicated as monotherapy for the treatment of adults with mild to moderate type 1 Gaucher disease for whom enzyme replacement therapy is not a therapeutic option (eg, due to allergy, hypersensitivity, or poor venous access). 

Type 1 Gaucher disease is caused by a functional deficiency of glucocerebrosidase, the enzyme that mediates the degradation of the glycosphingolipid glucosylceramide. Miglustat works by reducing the rate of glycosphingolipid biosynthesis so that the amount of glycosphingolipid substrate is reduced to a level which allows the residual activity of the deficient enzyme to be more effective. 

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