In addition to two previous pivotal Phase II trials by TranskaryoticTherapies, which demonstrated that Replagel (agalsidase alfa) enzyme therapy is a successful treatment for Fabry Disease (Marketletter October 16, 2000), the company is undertaking further trials to evaluate the effect of Replagel in patients who have received renal transplants, and in pediatric patients. TKT, and its main rival, Genzyme's alpha-L-iduronidase, have both filed for marketing approval for their enzyme replacement products with the US Food and Drug Administration, and final European market authorization for both products is expected soon.
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