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Article: FDA Deals Blow to TKT Drug; Panel Says Clinical Data Don't Justify Approval.
- Article from:
- Knight Ridder/Tribune Business News
- Article date:
- January 15, 2003
CopyrightCOPYRIGHT 2003 Knight-Ridder/Tribune Business News. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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By Naomi Aoki, The Boston Globe Knight Ridder/Tribune Business News
Jan. 15--BETHESDA, Md.--After two days of deliberations, a Food and Drug Administration panel yesterday may have dashed Transkaryotic Therapies' chances of ever marketing its drug, Replagal, used to treat a rare inherited disorder known as Fabry disease, in the United States.
Although panel members were split on the issue, most agreed that the data presented by TKT on Replagal did not justify approval at this time. Under normal circumstances, the decision might delay the drug's approval. But this case is anything but normal and has served to bring into bold relief the increasing ...