FDA reviewer rebuffs Symlin

FDA medical review documents released on Wednesday recommend that Amylin's Symlin pramlintide not be approved to treat Type I and Type II diabetes. On Thursday, the Endocrinologic and Metabolic Advisory Committee will meet to review the NDA for Symlin, an analog of the endogenous pancreatic hormone amylin.

"Pramlintide reduces postprandial hyperglycemia during the first few weeks of treatment, but the long-term reduction in HbA1c is trivial and is completely overshadowed by the risk of severe hypoglycemia," according to medical reviewer Robert Misbin. "Particularly alarming is the number of patients that had life-altering events on pramlintide related to hypoglycemia. The trials deviated so much from good medical practice that they provide little insight into which patients would benefit from pramlintide or how pramlintide should be used." ...