FDA approves once-weekly injection for type 2 diabetes
The US Food and Drug Administration approved on Friday the first once-weekly injection that improves glycemic control in people with type 2 diabetes, according to a news release from Amylin Pharmaceuticals, Inc.
Amylin's injectable prescription medicine Bydureon provides a controlled release of exenatide throughout the week. It helps the body make its own insulin when needed and improves blood glucose levels in adults with type 2 diabetes.
Bydureon should be used with diet and exercise. Amylin does not recommended Bydureon as the first medication to treat diabetes.
Amylin plans to make Bydureon available in pharmacies nationwide in February. Patients can self-administer the suspension by subcutaneous injection.
The approval of Bydureon was based on results of a clinical trial as well as clinical experience with Byetta, Amylin's twice-daily form of exenatide that has been available in the US since June 2005.
In the 24-week clinical trial, patients taking Bydureon reduced A1C by 1.6 percentage points from baseline, according to Amylin. A1C is a measure of average blood sugar over three months. Patients also lost an average of 5.1 pounds during the trial program as well.
One adverse side effect noted in the trial included nausea by 14 percent of patients. Others included diarrhea, upper respiratory tract infection and injection site nodules. No major hypoglycemic events were noted.
Other common side effects are headache, vomiting, constipation, itching at the injection site, and indigestion.
Bydureon is not for people with type 1 diabetes or people with diabetic ketoacidosis. The drug is not recommended for use in children.
Exanatide has been associated with acute pancreatitis. Bydureon should not be used in people with a history of severe kidney problems as it may cause kidney problems and kidney failure.
People with type 2 diabetes should consult their treating physician to discuss their diabetes management plan.
Source: Amylin Pharmaceuticals, Inc.