The newly approved type 2 diabetes drug  Bydureon, made by Amylin Pharmaceuticals and Alkermes plc, is now available by prescription in U.S. pharmacies. Bydureon is the first and only once-weekly treatment for type 2 diabetes.  It was approved by the US FDA on January 27th 2012 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. The approval was based on safety and efficacy data from the DURATION clinical trial program, in which treatment with  Bydureon  resulted in improvements in...

Amylin Pharmaceuticals, Eli Lilly and Alkermes announced new analyses from the DURATION-3 and DURATION-4 trials demonstrating patients treated with the investigational medication Bydureon (exenatide extended-release for injectable suspension) experienced significant improvements in select cardiovascular risk factors, in comparison to patients who received commonly prescribed diabetes treatments. The analyses showed that patients receiving Bydureon for the treatment of type 2 diabetes experienced improvements in composite endpoints...

Amylin, Eli Lilly and Alkermes, announced results from long-term extensions of the DURATION-1 and 3 studies evaluating Bydureon (exenatide extended-release for injectable suspension), an investigational medication for type 2 diabetes. The studies will be presented at the 71st Scientific Sessions of the American Diabetes Association. Data from the DURATION-1 study showed that after three years, patients receiving Bydureon experienced a significant reduction in A1c (1.6 percentage points) and weight (5.1 pounds) compared to...

The European Commission has granted marketing authorization to Eli Lilly, Amylin Pharmaceuticals and Alkermes’ type 2 diabetes drug Bydureon (exenatide extended-release for injectable suspension).  Bydureon is a glucagon-like peptide-1 (GLP-1) receptor agonist, and is the first once-weekly treatment for type 2 diabetes. It delivers glycemic control in a single weekly dose and is indicated for the treatment of type 2 diabetes in adult patients in combination with metformin, a sulfonylurea, a thiazolidinedione, metformin...

Eli Lilly and Company, Amylin Pharmaceuticals and Alkermes announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending approval of Bydureon for injection in the European Union for the treatment of type 2 diabetes in combination with certain oral therapies. This application to the European regulatory authorities is for use of Bydureon,exenatide 2 mg powder and solvent for prolonged release suspension, as a once-weekly dose to...

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...

In the complete response letter regarding the New Drug Application (NDA) for Bydureon (exenatide extended-release for injectable suspension) issued Tuesday the FDA requested Amylin Pharmaceuticals, Eli Lilly and Alkermesa conduct a thorough QT study which would look at the new drug’s effect on patients’ heart rates. Additionally the FDA requested the results of the DURATION-5 study to evaluate the efficacy and the labeling of the safety and effectiveness of the commercial formulation of Bydureon. Bydureon is a...

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. announced results from DURATION-4, the fourth in a series of studies designed to test the superiority of Bydureon (exenatide extended-release for injectable suspension), an investigational type 2 diabetes therapy, as compared to other type 2 diabetes medications. The 26-week clinical study compared Bydureon monotherapy to Januvia(R) (sitagliptin), Actos(R) (pioglitazone HCI) or metformin, three oral type 2 diabetes medications commonly prescribed early in...

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. announced that the U.S. Food and Drug Administration has classified the Bydureon(TM) complete response as a Class 2 resubmission and assigned a new Prescription Drug User Fee Act (PDUFA) action date of October 22, 2010. Bydureon (pronounced by-DUR-ee-on) is the proposed brand name for exenatide once weekly. It is an investigational, extended-release medication for type 2 diabetes designed to deliver continuous therapeutic levels of...

Amylin Pharmaceuticals Inc., Eli Lilly and Company and Alkermes, Inc. today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for BYDUREON(TM). In the complete response letter there are no requests for new pre-clinical or clinical trials. Requests raised in the letter primarily relate to the finalization of the product labeling with accompanying Risk Evaluation and Mitigation Strategy (REMS) and clarification of existing manufacturing...