US Approval of Zavesca


Gauchers News Contents


The US Food and Drug Administration has approved Zavesca for the treatment of adult patients with mild to moderate Type 1 Gauchers disease for whom enzyme replacement therapy is not a therapeutic option.


The FDA approved Zavesca in August 2003 for the treatment of adult patients with mild to moderate Type 1 Gauchers disease for whom enzyme replacement therapy is not a therapeutic option (eg due to constraints such as allergy, hyper-sensitivity or poor venous access).

Women who are or may become pregnant should not take it.

Zavesca is the first oral treatment for Gauchers disease and has already been approved in the European Union under similar indications. It is the first in a new class of drugs known as substrate reduction therapy which reduces the amount of lipid (fatty material) production to a level which can effectively be cleared by the naturally occurring enzyme, glucocerebrosidase, in the cells


Gauchers News Contents

Source: Gauchers News October 2003.
© Copyright Gauchers Association Ltd 2003.