On the day following the Avandia recommendation, the same Food and Drug Administration panel recommended approval of Takeda Pharmaceuticals' drug Actos. The FDA hasn't yet finished its review of the data on Actos' effectiveness, so the agency only asked the panel to comment on Actos' safety profile.
In Takeda's six U.S. studies, more than 2,500 patients took Actos; of those patients, none developed jaundice or had severe elevation in liver enzyme levels. The panel agreed that concerning safety, Actos and Avandia should be considered similar. In a written statement issued at the FDA panel meeting, Warner-Lambert said if the two drugs are approved, it will conduct head-to-head trials comparing them to Rezulin. More than 100 clinical trials are currently under way involving Rezulin for a variety of therapeutic indications.
Takeda has also partnered with a giant in the diabetes market, Eli Lilly, to co-promote the drug for sale in the United States.
COPYRIGHT 1999 Lebhar-Friedman, Inc.
COPYRIGHT 2000 Gale Group
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