FDA Approves New Diabetes Drug Symlin
Injectable Drug Helps Control Blood Sugar in Type 1 and Type 2 Diabetes
WebMD News Archive
The FDA has approved a drug called Symlin to help control blood sugar in people with type 1 and type 2 diabetes who do not achieve good blood sugar control with insulin therapy.
Symlin, an injectable drug, is a manufactured version of human amylin, a hormone secreted along with insulin. Symlin is given at mealtimes and will not replace insulin. Instead, it is only to be used with insulin to help lower blood sugar during the three hours after meals, says the FDA.
Symlin is also not intended for everyone with diabetes, says the web site of the drug's maker. It's only for patients who are already using medicine as advised but still need more help to control blood sugar.
"Symlin is to be used in addition to insulin therapy in patients who cannot achieve adequate control of their blood sugars on intensive insulin therapy alone," says an FDA statement.
Symlin is made by Amylin, a San Diego biotech company. In January 2004, Amylin withdrew its application to sell Symlin in Switzerland when questions arose about side effects including nausea and hypoglycemia (low blood sugar). Both of those side effects are noted on the drug's labeling and medication guide.
Amylin has another diabetes drug, Exenatide, awaiting FDA approval. Late last year, John Buse, MD, PhD, told WebMD he expected Exenatide to be approved for type 2 diabetes. Buse directs the Diabetes Care Center at the University of North Carolina's medical school.
"So-called 'tight' control of blood sugar is desirable in all diabetes patients," says the FDA. Closely controlling blood sugar can help reduce risks of long-term problems tied to diabetes, including blindness, kidney disease, and heart disease.
Besides insulin, Symlin will be the only therapy for treating type 1 diabetes. Several oral medicines are already available for people with type 2 diabetes.
Candidates for Symlin
Symlin has not been evaluated for use by children. The FDA says the drug should only be used if patients:
- Are already using their insulin as prescribed but still need better blood sugar control
- Will follow their doctor's instructions exactly
- Will follow up with their doctor often
- Will test their blood sugar levels before and after every meal, and at bedtime
- Understand how to adjust Symlin and insulin doses