Amylin Pharmaceuticals Inc announced the submission of a New Drug Application (NDA) amendment for its lead diabetes drug candidate, Symlin (pramlintide acetate), to the U.S. Food and Drug Administration (FDA). The Company is seeking approval to market Symlin as an adjunctive therapy to insulin for the treatment of people with type 1 or type 2 diabetes who use insulin. The amendment includes results from a dose-titration study in type 1 diabetes and four smaller pharmacology studies. Upon acceptance of the submission by the FDA, the amendment has a Prescription Drug User Fee Act (PDUFA) review time of six months.

"Amylin's clinical and regulatory teams oversaw the swift enrollment, completion and thorough data analysis of the final Symlin studies, which involved more than 300 subjects," said Joann L. Data, Senior Vice President of Regulatory Affairs and Quality Assurance. "We believe that we have addressed all the outstanding items in the Approvable Letter and will work with the FDA as they review our submission."

Symlin is an analog of human amylin, a hormone secreted with insulin by the beta cells in the pancreas. Other than insulin and insulin analogues, Symlin is the first potential treatment addressing glucose control for patients with type 1 diabetes that has completed Phase 3 clinical trials since the discovery of insulin over 80 years ago. The company submitted the original NDA in December of 2000. In October 2001, Amylin received an Approvable Letter from the FDA for both type 1 and type 2 diabetes. Final approval is subject to the FDA's satisfaction with the results from the dose titration study and the four smaller pharmacology studies already completed. If Symlin is approved for patient use, Amylin plans to market the product in the U.S. with the sales force it established to co-promote Eli Lilly and Company's Humatrope earlier this year.