Anemia

Investigational New Drug Application Submitted for Oncology Indication

Published in Blood Weekly, January 27th, 2000

Transkaryotic Therapies, Inc, (TKT) announced the completion of dosing for the pivotal Phase III clinical trials of Gene-Activated erythropoietin (GA-EPO) in the United States and United Kingdom by its partner, Aventis Pharma.

The studies were designed to assess the safety and efficacy of GA-EPO as a treatment for anemia of renal failure in dialysis and pre-dialysis patients and are intended to support filing for market approval in both the United States and United Kingdom. The data from the trials are being collected, and, if the results are positive, the filings of a Biologics License Application (BLA) to the US Food and Drug Administration and a Marketing...

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Source: Blood Weekly (2000-01-27)

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