Amylin Pharmaceuticals, Inc. 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 procedure does not allow for another supplemental submission of data at this stage, therefore, the company has decided to withdraw its application.
"We are currently evaluating our Symlin regulatory options in markets in other countries, including resubmission in Switzerland. However, at this time our priority is to gain regulatory approval in the US," said Joann Data, MD, PhD, senior vice president of Regulatory Affairs and Quality Assurance for Amylin Pharmaceuticals, Inc. "Currently, Amylin's primary focus is to work with the FDA to answer questions posed in the Symlin approvable letter received in December 2003."
The revision in Amylin's Swiss regulatory strategy for Symlin does not affect regulatory strategies being pursued in the US In December 2003, Amylin received a second Approvable Letter from the FDA for both type 1 and insulin-using subjects with type 2 diabetes. Final approval is subject to the outcome of further discussions with the FDA.