BioCentury
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Amylin to amend Symlin NDA

December 27, 2001 8:00 AM UTC

AMLN said it will submit in the second half of 2002 an amendment to its NDA for Symlin pramlintide to treat Type I and II diabetes as an adjunct to insulin. In October, the company received an approvable letter for the product, and said that approval would require additional clinical work (see BioCentury, Oct. 15). AMLN said it plans to run a double-blind, placebo-controlled dose titration study in 250 patients with Type I diabetes who are actively trying to improve glucose control. The study, which is expected to start by the end of the first quarter, will focus on safety and also will examine HbA1c levels and insulin usage. The company also will run short-term pharmacokinetic-pharmacology studies.

In July, the FDA's the Endocrinologic and Metabolic Drugs Advisory Committee voted 8-1 and 6-3 against approval of Symlin to treat Type I and II diabetes, respectively (see BioCentury, July 30). At that time, panel members expressed concern about the relatively high incidence of hypoglycemia that occurred during the first 4 weeks of therapy. The panel recommended that AMLN run a double-blind trial titrating dosages of insulin and use a reduced dose of Symlin during initiation of therapy in Type I diabetes patients. ...