Byetta Label Revised

Earlier this month, Amylin (AMLN - Analyst Report) and Eli Lilly (LLY - Analyst Report) announced that the U.S. Food and Drug Administration (FDA) has implemented label changes for Byetta (exenatide) which is indicated for the treatment of type II diabetes.
 
The revised label will inform both patients as well as doctors about the possibility of kidney function problems arising with the use of Byetta. The label has been revised to include information on post-marketing reports of altered kidney function, including acute renal failure and insufficiency.
 
The label says that Byetta should not be used in patients with end-stage kidney disease or several kidney impairment and recommends that physicians should be cautious about starting patients on Byetta or increasing their doses if the patients have moderate kidney problems or if they have had a kidney transplant.
 
While the revised label could restrict Byetta application in certain cases, we are pleased to see that the FDA did not issue a “black box” warning for the drug, which would have had a devastating impact on sales. The FDA said that it has received about 78 reports of problems with kidney functioning in patients using Byetta from April 2005 through October 2008. As more than 6.6 million prescriptions for Byetta were dispensed until September 2008, the agency noted that the number of kidney problems represented a small percentage of the total number of patients on Byetta therapy.
 
The label change comes a few days after the FDA granted approval for expanded use of the drug. Amylin and Eli Lilly received approval to market Byetta as a monotherapy or stand-alone treatment for type II diabetes patients.
 
The expanded use opens up a wider patient base for Byetta, which was previously approved only for patients who were taking other diabetes medicines and had not achieved adequate control of blood sugar. Diabetes is the fifth leading cause of death by disease in the United States and is estimated to affect more than 24 million people in the country, and about 246 million adults worldwide.
 
With an obesity partnership in place and Byetta labeling issues taken care of, we expect investor focus to remain on Byetta’s performance and the approval of exenatide once-weekly. We maintain our Neutral recommendation on the stock.

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