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Second Approvable Letter Issued for Pramlintide
SAN DIEGO, Dec. 17 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has issued a second approvable letter for SYMLIN® (pramlintide acetate), Amylin's lead drug candidate being studied for the treatment of people with type 1 and insulin-using type 2 diabetes. The FDA has requested additional clinical data to identify a patient population and method of use for SYMLIN® where there is no increased risk of significant hypoglycemia or where there is an added benefit that clearly counterbalances any potential for increases in episodes of hypoglycemia. The Company believes that existing data generated since the submission of the amendment to the SYMLIN New Drug Application in June 2003 could provide the necessary data requested by the FDA. This includes data from the open-label extension of the dose-titration study included in the amendment and a large open-label study initiated earlier this year. Amylin has requested a discussion with the agency regarding specific requirements for approval.
Amylin Pharmaceuticals is a biopharmaceutical company dedicated to developing innovative medicines to improve the lives of people with metabolic diseases. Further information on Amylin and its pipeline in metabolism is available at http://www.amylin.com/.
Source: Amylin Pharmaceuticals, Inc.