The European Commission has granted marketing authorization to Byetta (exenatide twice-daily) as an adjunctive therapy to basal insulin, with or without metformin and/or Actos® (pioglitazone), for the treatment of type 2 diabetes in adults who have not achieved adequate glycemic control with these agents. The EU approval was given after a clinical trial of patients using fixed-dose  Byetta with titrated basal insulin.  The patients in the trial achieved better postprandial and overall glycemic control, without weight gain...

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion in the European Union (EU) for the expanded use of Byetta (exenatide twice-daily) as an add-on therapy to basal insulin, with or without metformin and/or Actos® (pioglitazone), for the treatment of type 2 diabetes in adults. The CHMP’s decision is now referred for final action to the European Commission, which has the authority to approve medicines for the EU. The Commission usually decides on...

The U.S. Food and Drug Administration (FDA) has approved a new use for Amylin and Eli Lilly’s type 2 diabetes drug, Byetta (exenatide) injection.  Byetta is now approved as an add-on therapy to insulin glargine (Lantus), with or without metformin and/or a thiazolidinedione (TZD), for adults with type 2 diabetes who are not achieving adequate glycemic control on insulin glargine alone. The FDA approved Byetta as an add-on therapy to Lantus following a clinical trial where patients using Byetta with insulin glargine achieved...

New data from two extension studies presented by Novo Nordisk at the 71st Annual Scientific Sessions of the American Diabetes Association (ADA) show that Victoza (liraglutide [rDNA origin] injection), taken once-daily, in combination with metformin and/or sulfonylurea, helped patients achieve blood sugar control after switching from other commonly used type 2 diabetes therapies Byetta (exenatide) and Januvia (sitagliptin). Although not a weight loss product, the data also demonstrate that patients experienced weight loss when...

Results from a retrospective analysis of more than 778,000 patients showed the addition of Byetta (exenatide) injection to pre-existing diabetes treatment regimens was associated with a reduced likelihood of heart failure, especially among patients receiving insulin. These findings were presented by Amylin and Eli Lilly in a poster session at the 71st Scientific Sessions of the American Diabetes Association in San Diego on June 25. The retrospective analysis used data from the GE Healthcare Centricity electronic medical record...

Amylin Pharmaceuticals announced that it has filed a lawsuit against Eli Lilly.  Amylin alleges Lilly is engaging in anticompetitive activity and breaching its strategic alliance agreements to maximize commercialization of exenatide currently marketed as BYETTA® (exenatide) injection.  In 2002 the two companies entered an alliance for the global development and commercialization of exenatide, a medicine indicated as a first line treatment for type 2 diabetes. Exenatide is also the active ingredient in BYDUREON(TM) (exenatide...

Positive results from a phase 2 study evaluating the effects of a once-monthly injectable suspension formulation of exenatide on glycemic control in patients with type 2 diabetes were announced by Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. Exenatide once monthly is a new, extended-release formulation of exenatide, the active ingredient in Byetta (exenatide) injection, which is given twice daily. Exenatide once monthly is based on the same Medisorb(R) microsphere technology used in Bydureon. The...

Amylin Pharmaceuticals, Inc.and Eli Lilly and Company have submitted a supplemental New Drug Application (sNDA) to the FDA for the expanded use of Byetta (exenatide) injection as an add-on therapy to basal insulin for adults with type 2 diabetes. Byetta, the first marketed GLP-1 receptor agonist, was approved in the U.S. in April 2005 for the treatment of type 2 diabetes as add-on therapy to diet and exercise for adult patients not achieving adequate glycemic control using commonly prescribed oral diabetes medications. In October...

Combining the diabetes drug exenatide (Byetta) with insulin provides better blood sugar control in patients with type 2 diabetes than insulin alone and helps promote weight loss, according to a new study published on-line Dec. 7, 2010 by the Annals of Internal Medicine. The 30-week study was conducted at 59 centers in five countries (Greece, Israel, Mexico, the U.K. and the U.S.) with 261 participants. All were adults with type 2 diabetes who were taking once-daily injections of Lantus (insulin glargine), either alone or with...

Results of a new retrospective study of nearly 375,000 type 2 diabetes patients evaluating the incidence of events related to cardiovascular disease (CVD) and all-cause hospitalizations among initiators of BYETTA(R) (exenatide) injection compared to initiators of other commonly used diabetes medications were presented by Eli Lilly and Amylin Pharmaceuticals at the American Heart Association Scientific Sessions in Chicago. In the study, BYETTA was associated with a lower incidence of CVD-related events than insulin, thiazolidinediones...