TKT Replagal Approval Path Will Begin With Request For Protocol Assessment
Executive Summary
Transkaryotic Therapies hopes to begin discussion on a potential approval pathway for the Fabry disease agent Replagal in November via a request for an FDA special protocol assessment, CEO Michael Astrue said during an Oct. 29 conference call
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TKT gives up on Replagal
Transkaryotic Therapies withdraws BLA for Replagal in Fabry disease after FDA indicates that a comparison trial against Genzyme's Fabrazyme would be a prerequisite for approval. TKT submitted a special protocol assessment to the agency in November to open a discussion about a potential regulatory pathway (1"The Pink Sheet" Nov. 10, 2003, p. 17). Replagal and Fabrazyme were on near-identical development tracks for orphan drug approval; FDA cleared Genzyme's product in April (2"The Pink Sheet" April 28, 2003, p. 3)...
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Transkaryotic Therapies will decide this summer after meeting with FDA whether to conduct additional clinical trials with its Fabry disease agent Replagal