Monday, Amylin Pharmaceuticals, Inc. (AMLN), Eli Lilly and Company (LLY) and Alkermes, Inc. (ALKS) announced that the U.S. Food and Drug Administration, or FDA denied approval for its New Drug Application, or NDA for Bydureon, an investigational type II diabetes drug.
The FDA issued a complete response letter to the companies for Bydureon, seeking additional information regarding labeling finalization; Risk Evaluation and Mitigation Strategy, or REMS, and clarification on existing manufacturing processes.
Bydureon is the proposed trade name in question. It is a once-weekly formulation of exenatide, the active ingredient in Amylin's Byetta injection. Byetta is available in the U.S. since June 2005. Byetta is "the first FDA-approved GLP-1 receptor agonist" for the treatment of type II diabetes. In fiscal 2009, Amylin booked net product sales of $754.0 million, of which $667.6 million was from sale of Byetta. Bydureon and Byetta belong to the glucagon-like peptide-1 receptor agonist class of medications.
The NDA for Bydureon was submitted in May 2009 and accepted by the FDA in July 2009. Bydureon is developed by Amylin, Lilly and Alkermes, for the treatment of type II diabetes based on Alkermes' proprietary Medisorb technology for long-acting medications. Bydureon is an investigational, extended-release medication for type II diabetes designed to deliver continuous therapeutic levels of exenatide in a single weekly dose.
Amylin informed that the FDA did not request new pre-clinical or clinical trials. Also, requests related to the December 2009 observations from the FDA's pre-approval inspection at the Ohio manufacturing facility were not repeated, as the issues were addressed already.
Diabetes, the fifth leading cause of death by disease in the U.S., affects more than 24 million people in the U.S. and an estimated 285 million adults worldwide. About 90% to 95% of those affected have type II diabetes. Diabetes draws nearly $174 billion per year in direct and indirect medical expenses.
"This is a significant step forward in our ability to bring this important therapy to patients. We have a clear path forward and are working diligently to submit our response to the FDA in the next few weeks," said Orville G. Kolterman, senior vice president of research and development, Amylin Pharmaceuticals.
LLY is trading at $35.92, on the NYSE.
AMLN is up 11.85% or $2.32, at $22.66 and ALKS is trading at $13.83, up 1.62 or 13.27%, on the Nasdaq.
For comments and feedback contact: editorial@rttnews.com
June 05, 2026 16:18 ET A busy week for economic news flow saw a slew of reports being released that reflected the trends in the U.S. labor market. In Europe, economic growth and inflation data gained attention as the European Central Bank and Bank of England head for policy session later in the month. In Asia, the monetary policy session of the Indian central bank was in focus as the country, a major oil importer, reels under the pressures of a weaker rupee and rising inflation.