Amylin submits EU application for Symlin

Amylin Europe, a subsidiary of Amylin Pharmaceuticals, has submitteda marketing authorization application to the European Medicines Evaluation Agency for Symlin (pramlintide acetate), with a filing expected in the second quarter of this year. Symlin, an analog of human amylin which is secreted by beta cells in the pancreas, is a potential adjunct therapy to insulin for the treatment of patients with type 1 or type 2 diabetes who use insulin.

Amylin submitted a New Drug Application for Symlin last year to the US Food and Drug Administration (Marketletter December 11, 2000) and a review by the FDA's Endocrinologic and Metabolic Drugs Advisory Committee is scheduled for July 26.