Amylin Submits New Diabetes Data to FDA
Amylin Pharmaceuticals Inc. of San Diego said it had submitted new information to the Food and Drug Administration about Symlin in its 17-year quest to market the experimental injectable drug for diabetes.
The FDA told Amylin in January that it was concerned about hypoglycemia, or low blood sugar, which can lead to nausea, confusion and brain injury. The company said that it recently completed a new clinical study and found no more cases of hypoglycemia in the group of diabetics on Symlin than in the group of patients on a placebo.
Symlin is a synthetic version of a natural hormone that acts with insulin to control blood sugar. Amylin tested the drug in both juvenile and adult-onset diabetes. Some in the financial community believe Symlin could have peak sales of $300 million.
Amylin said it expected a response from the FDA within six months.
Denise Gellene
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