Bydureon | Page 2 of 2

Amylin’s Type 2 Diabetes Drug, BYDUREON, Fails to Meet Primary End Point in New Study

Amylin Pharmaceuticals, Eli Lilly and Alkermes announced the top-line results from the DURATION-6 study comparing once weekly BYDUREON (exenatide extended-release for injectable suspension), an investigational type 2 diabetes therapy, to Novo Nordisk's daily Victoza (liraglutide (rDNA origin) injection). Both drugs are members of the class of type 2 diabetes medications known as glucagon-like peptide-1 (GLP-1) receptor agonists...

FDA Requests Further Testing On Amylin’s New Type 2 Diabetes Drug

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...

FDA Requests Further Testing On Amylin’s New Type 2 Diabetes Drug

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...

New Type 2 Diabetes Drug Bydureon Shows Better Results Than Januvia

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...

FDA Classifies Bydureon Complete Response as a Class 2 Resubmission

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...

Amylin, Lilly and Alkermes Receive FDA Complete Response Letter for Exenatide Once Weekly

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...