Amylin and Lilly win FDA approval for expanded use of diabetes drug

Tue. November 03, 2009; Posted: 05:09 AM

Nov 03, 2009 (Datamonitor via COMTEX) -- AMLN | Quote | Chart | News | PowerRating -- Amylin Pharmaceuticals, a biopharmaceutical company, and Eli Lilly and Company have reported that the FDA has approved an expanded indication for Byetta injection.

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.

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 new label also 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.

Byetta is now approved for use as a stand-alone medication 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.

Orville Kolterman, senior vice president of R&D 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. Type 2 diabetes is a complex disease, so it is essential that healthcare professionals and their patients have a wide array of treatments that can effectively control blood glucose levels."

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For full details on Amylin Pharmaceuticals (AMLN) click here. Amylin Pharmaceuticals (AMLN) has Short Term PowerRatings of 4. Details on Amylin Pharmaceuticals (AMLN) Short Term PowerRatings is available at This Link.

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