Innovative Diabetes Drug Wins Approval
First Type 1 treatment since insulin
THURSDAY, March 17, 2005 (HealthDay News) -- The U.S. Food and Drug Administration has approved the Amylin Pharmaceuticals drug Symlin to treat both type 1 and type 2 diabetes. An agency statement said the new drug represented the only approved type 1 therapy since insulin was introduced more than 80 years ago.
Symlin is a synthetically produced form of the naturally occurring hormone amylin, which helps the body regulate blood glucose levels. The drug was approved to be used in conjunction with insulin to help diabetics better manage their blood sugar in the three hours after eating, the FDA said.
The agency said a primary risk of the new drug is hypoglycemia, a condition caused when a person's blood sugar drops too low to fuel the body's normal activities. The agency said it was also concerned about so-called "off-label" use by patients for whom the drug was prescribed in ways that weren't recommended.
Symlin should only be used by patients who are already using insulin but still need better blood sugar control, the FDA said. The drug, which was studied in about 5,000 people, hasn't been evaluated in diabetics under age 18, the agency said.
This FDA site has much more about diabetes.