The technology encapsulates activemedication into polymer-based microspheres that are injected into the bodywhere they degrade slowly, gradually releasing the drug in a controlled mannerto provide continuous therapeutic exenatide levels in plasma.
Safety Profile
Exenatide once weekly was well tolerated during the first 30 weeks oftreatment and the following 22-week, open-ended treatment period with overalltolerability improving over the course of the study. No major hypoglycemiaevents regardless of background therapy, were observed with exenatide onceweekly. Cases of minor hypoglycemia with exenatide once weekly and withBYETTA use were limited to patients using background sulfonylurea therapy. Inboth groups, nausea was predominantly mild and transient and occurred lessfrequently in exenatide once weekly patients. Patients switching from BYETTAto exenatide once weekly did not experience a significant increase in nauseafollowing the transition. The antibody profiles of patients treated in thisstudy were consistent with the previously reported profiles of BYETTA andexenatide once weekly. These data further supported the known safety profileof the exenatide molecule.
About BYETTA(R) (exenatide) injection
BYETTA is the first and only FDA-approved incretin mimetic for thetreatment of type 2 diabetes. BYETTA exhibits many of the same effects as thehuman incretin hormone glucagon like peptide-1 (GLP-1). GLP-1 improves bloodsugar after food intake through multiple effects that work in concert on thestomach, liver, pancreas and brain. BYETTA is approved by the FDA for use bypeople with type 2 diabetes who are unsuccessful at controlling their bloodsugar levels. BYETTA is an add-on therapy for people currently usingmetformin, a sulfonylurea, or a thiazolidinedione. BYETTA provides sustainedA1C control, low incidence of hypoglycemia when used with metformin or athiazolidinedione, and progressive weight loss. BYETTA was approved in April2005 and has been used by approximately one million patients since itsintroduction. For full prescribing information, visit www.BYETTA.com.
About Diabetes
Diabetes affects more than 21 million in the United States and anestimated 246 million adults worldwide.(1)(2) Approximately 90-95 percent ofthose affected have type 2 diabetes. Diabetes is the fifth leading cause ofdeath by disease in the United States and costs approximately $132 billion peryear in direct and indirect medical expenses.(3)
According to the Centers for Disease Control and Prevention's NationalHealth and Nutrition Examination Survey, approximately 60 percent of peoplewith diabetes do not achieve their target blood sugar levels with theircurrent treatment regimen.(4) In addition, 85 percent of type 2 diabetespatients are overweight and 55 percent are considered obese.(5) Data supportthat weight loss (even a modest amount) supports patients in their efforts toachieve and sustain glycemic control.(6)(7)
Important Safety Information for BYETTA
BYETTA improves glucose (blood sugar) control in adults with type 2diabetes. It is used with metformin, a sulfonylurea, or a thiazolidinedione.BYETTA is not a substitute for insulin in patients whose diabetes requiresinsulin treatment. BYETTA is not recommended for use in patients with severeproblems digesting food or those who have severe disease of the stomach orkidney.
When BYETTA is used with a medicine that contains a sulfonylurea,hypoglycemia (low blood sugar) is a possible side effect. To reduce thispossibility, the dose of sulfonylurea medicine may need to be reduced whileusing BYETTA. Other common side effects with BYETTA include nausea, vomiting,diarrhea, dizziness, headache, feeling jittery, and acid stomach. Nausea isthe most common side effect when first starting BYETTA, but decreases overtime in most patients.
If patients experience the following severe and persistent symptoms (aloneor in combination): abdominal pain, nausea, vomiting, or diarrhea, they shouldtalk to their healthcare provider because these symptoms could be signs ofserious medical conditions. BYETTA may reduce appetite, the amount of foodeaten, and body weight. No changes in dose are needed for these side effects.These are not all of the side effects from use of BYETTA. A healthcareprovider should be consulted about any side effect that is bothersome or doesnot go away.
For full prescribing information, visit www.BYETTA.com.
About Amylin, Lilly and Alkermes
Amylin, Lilly, and Alkermes are working together to develop exenatide onceweekly, a subcutaneous injection of exenatide for the treatment of type 2diabetes based on Alkermes' proprietary technology for long-actingmedications.
