The FDA is evaluating unpublished new findings by a group of academic researchers that suggest an increased risk of pancreatitis, or inflammation of the pancreas, and pre-cancerous cellular changes called pancreatic duct metaplasia in patients with type 2 diabetes treated with a class of drugs called incretin mimetics.
Tag: Byetta
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 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)...
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...
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..
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...
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...
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...
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...
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...