Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) today announced that the companies have submitted their reply to a complete response letter issued in October 2010 by the U.S. Food and Drug Administration (FDA) regarding BYDUREON™ (exenatide extended-release for injectable suspension), an investigational medication for type 2 diabetes. The companies expect to receive an updated Prescription Drug User Fee Act (PDUFA) action date from the FDA within the next two weeks. Since the reply included additional data, it will likely be categorized as a Class 2 resubmission requiring up to six months for review.
“We worked expeditiously to complete the requested tQT study and consulted with the FDA throughout the process”
The reply submission includes results from the recently completed thorough QT (tQT) study, which showed that exenatide, at and above therapeutic levels, did not prolong the corrected QT interval in healthy individuals as defined by the FDA's published guidance. The reply also contains results from the DURATION-5 study, which compared the commercial formulation of BYDUREON to BYETTA® (exenatide) injection. Additionally, it includes an update of safety information from studies ongoing or completed since the last submission, as is standard practice in a complete response scenario.
"We worked expeditiously to complete the requested tQT study and consulted with the FDA throughout the process," said Christian Weyer, M.D., senior vice president, research and development, Amylin Pharmaceuticals. "We are confident that the study results and our detailed submission have addressed the requirements outlined by the FDA, and we remain committed to making BYDUREON available to patients in the U.S. as soon as possible."
BYDUREON is the proposed brand name for exenatide extended-release for injectable suspension. It is an investigational 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, which has been available in the U.S. since June 2005 and is used in more than 70 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 New Drug Application (NDA) for BYDUREON was submitted in May 2009. It is based on safety and efficacy data from the DURATION clinical trial program and the BYETTA NDA, as well as post-marketing experience with BYETTA. The FDA issued complete response letters to the companies in March 2010 and October 2010.
BYDUREON received marketing authorization in the European Union in June 2011. It is available in the U.K. and will launch in other major European countries as soon as possible.
Amylin, Lilly and Alkermes