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 … Read more
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… Read more
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… Read more
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… Read more
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… Read more
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… Read more
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… Read more
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… Read more
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… Read more
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 processes. The companies view this response as a positive step forward… Read more
