TKT, Genzyme Fabry Disease Products Nearing January Review Deadline
Executive Summary
Transkaryotic Therapies and Genzyme are in a close race to introduce a Fabry disease enzyme replacement therapy.
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Genzyme/TKT Fabry Agents Receive Co-Exclusive Orphan Drug Status In EU
Genzyme's Fabrazyme and Transkaryotic Therapies' Replagal will split the 5,000-patient Fabry's disease market in Europe following the awarding of co-exclusive orphan status by the European Commission.
Genzyme/TKT Fabry Agents Receive Co-Exclusive Orphan Drug Status In EU
Genzyme's Fabrazyme and Transkaryotic Therapies' Replagal will split the 5,000-patient Fabry's disease market in Europe following the awarding of co-exclusive orphan status by the European Commission.
Transkaryotic Therapies Replagal
Company receives "complete review" letter for agalsidase alpha Jan. 1. FDA requests additional data and TKT "has initiated the collection of these data," the company says. Genzyme's Fabrazyme (agalsidase beta) is also receiving priority review at FDA for Fabry disease (1"The Pink Sheet" Dec. 18, 2000, p. 34)