Diabetes

Swiss regulatory application for Symlin withdrawn

Published in Obesity and Diabetes Week, February 2nd, 2004

Amylin Pharmaceuticals, Inc., (AMLN) announced receipt of correspondence from the Swiss Agency for Therapeutic Products (Swissmedic) indicating that Symlin could not be approved for marketing in Switzerland based on data received to date.

The Swissmedic indicated that they require additional clinical information to demonstrate the benefits of Symlin therapy relative to risks associated with adverse events, including nausea and hypoglycemia. Amylin submitted the original application in August 2001, and in March 2003 submitted a response to the original inquiries from the Swissmedic, which included an interim analysis of a Symlin dose-titration study. The Swiss regulatory...

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Source: Obesity and Diabetes Week (2004-02-02)

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