Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY) announced that the U.S. Food and Drug Administration (FDA) has approved more convenient patient storage instructions for BYETTA? (exenatide) injection.
BYETTA Pens can now be kept at a room temperature not to exceed 77 degrees F (25 degrees C) after first use.
With the updated label, refrigeration of BYETTA is no longer required after first use. Patients can now keep a BYETTA Pen at a temperature anywhere from 36 degrees F (2 degrees C) to 77 degrees F (25 degrees C) after first use. Until first use, BYETTA Pens must continue to be stored in a refrigerator between 36 degrees F (2 degrees C) and 46 degrees F (8 degrees C). These new, more convenient storage instructions will be provided to patients and healthcare professionals during the next few weeks. Patients now using BYETTA can immediately begin storing their current, in use BYETTA Pen at a room temperature not to exceed 77 degrees F (25 degrees C). BYETTA Pens should be protected from light and never frozen.
This change further enhances the convenience of BYETTA for patients. BYETTA is available in a simple-to-use 5 microgram and 10 microgram fixed dose pen device. Unlike insulin, the dose of BYETTA does not need to be adjusted based on the size of meals or amount of exercise, and no additional blood glucose monitoring is required.
“My patients already find BYETTA simple and easy to use,” said Deborah Hinnen, RN, ARNP, CDE, BC-ADM, FAAN, Diabetes Nurse Specialist and Coordinator of Diabetes Education Services, Mid America Diabetes Associates, Wichita, Kansas. “The ability to store the BYETTA Pen without the need for refrigeration after first use is an improved convenience that makes it even easier for people with type 2 diabetes to take advantage of the unique clinical benefits of BYETTA.”
Patients on BYETTA therapy at 2.5 years showed sustained A1C control with a secondary benefit of weight loss. BYETTA improved blood sugar control by lowering both post-meal and fasting (early morning) glucose levels, resulting in better long-term control as measured by A1C. BYETTA helps control blood sugar through five unique actions in one therapy, including the stimulation of insulin secretion only when blood sugar is high. BYETTA restores the first-phase insulin response (an activity of the cells in the pancreas that is lost in patients who have type 2 diabetes), decreases glucose output from the liver, regulates gastric emptying, and decreases food intake.