Amylin Pharmaceuticals (Amylin) and Eli Lilly have reported that the FDA has approved an expanded indication for Byetta (exenatide) injection. Byetta is now approved for use as a monotherapy along with diet and exercise to improve glycemic control in adults with type 2 diabetes. Previously, it was approved for use only in patients who were also taking other common diabetes medications and had not achieved adequate glycemic control.
The approval of Byetta as a monotherapy treatment was based on a clinical study of patients with type 2 diabetes who were unable to achieve glycemic control through diet and exercise alone.
The results of the study showed that patients treated with 5mcg or 10mcg of Byetta as monotherapy reduced their A1C, a measure of average blood sugar over three months, by 0.7% points and 0.9% points, respectively, and lost 6 pounds and 6.4 pounds, respectively.
In addition to the monotherapy indication, the FDA approved changes to the Byetta prescribing information to incorporate updated safety information, including pancreatitis-related language added to the warnings and precautions section. This update addresses the alert issued by the FDA in August 2008.
The company said that the new label expands upon existing language regarding use of Byetta in patients with renal impairment. In addition, the label has been amended to match the format the FDA currently uses for Prescribing Information.
Orville Kolterman, senior vice president of research and development at Amylin, said: “The expanded indication gives physicians the option to prescribe Byetta as a first-line treatment, increasing the number of patients who may benefit from the medication and providing an opportunity to treat patients with Byetta earlier in the disease.
“Patient safety is our foremost concern at Amylin and Lilly, and the Byetta Prescribing Information represents an important way to communicate the information that healthcare professionals and patients need in order to use the medication safely and effectively.Thus, the updated label offers the most current information about the benefit-risk profile of Byetta as a foundational therapeutic choice for people with type 2 diabetes.”