Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. announced that the US Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for Bydureon (exenatide for extended-release injectable suspension).
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 labelling with accompanying Risk Evaluation and Mitigation Strategy (REMS) and clarification of existing manufacturing processes.
The complete response letter does not contain requests related to the December 2009 observations from the FDA's pre-approval inspection at the Ohio manufacturing facility. All of those observations have been addressed.
"This is a significant step forward in our ability to bring this important therapy to patients," said Orville G Kolterman, M.D., senior vice president of research and development, Amylin Pharmaceuticals. "We have a clear path forward and are working diligently to submit our response to the FDA in the next few weeks."
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 exenatide in a single weekly dose. Bydureon is a once-weekly formulation of exenatide, the active ingredient in Byetta (exenatide) injection, which has been available in the US since June 2005 and is used in approximately 60 countries worldwide to improve glycemic control in adults with type 2 diabetes. Bydureon and Byetta belong to the glucagon-like peptide-1 (GLP-1) receptor agonist class of medications.
The NDA for Bydureon was submitted in May 2009 and accepted by the FDA in July 2009. It is based on data from the DURATION clinical trial programme, as well as more than seven years of clinical experience with Byetta.
Byetta the first FDA-approved GLP-1 receptor agonist for the treatment of type 2 diabetes. Byetta exhibits many of the same effects as the human incretin hormone glucagon-like peptide-1 (GLP-1). GLP-1 improves blood sugar after food intake through multiple effects that work in concert on the stomach, liver, pancreas and brain.
Byetta is an injectable prescription medicine that may improve blood sugar (glucose) control in adults with type 2 diabetes mellitus, when used with a diet and exercise programme. Byetta is not insulin and should not be taken instead of insulin. Byetta is not recommended to be taken with insulin. Byetta is not for people with type 1 diabetes or people with diabetic ketoacidosis.
Byetta provides sustained A1C control and low incidence of hypoglycemia when used alone or in combination with metformin or a thiazolidinedione, with potential weight loss. Byetta is not a weight-loss product. Byetta was approved in April 2005 and has been used by more than one million patients since its introduction.
Amylin, Lilly and Alkermes are working together to develop Bydureon, a subcutaneous injection of exenatide for the treatment of type 2 diabetes based on Alkermes' proprietary Medisorb technology for long-acting medications. Bydureon is not currently approved by any regulatory agencies.
Amylin Pharmaceuticals is a biopharmaceutical company dedicated to improving lives of patients through the discovery, development and commercialization of innovative medicines.
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations.
Alkermes, Inc. is a fully integrated biotechnology company committed to developing innovative medicines to improve patients' lives.