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. Additionally the FDA requested the results of the DURATION-5 study to evaluate the efficacy and the labeling of the safety and effectiveness of the commercial formulation of Bydureon.
Bydureon is a once-weekly version of the injectable treatment Byetta, which is taken twice daily. It is part of the broader GLP-1 class of drugs, which work by increasing the body’s insulin production. Bydureon is an investigational, extended-release medication for type 2 diabetes designed to deliver continuous therapeutic levels of exenatide in a single weekly dose. Byetta has been available in the U.S. since June 2005 and is used in more than 60 countries worldwide to improve glycemic control in adults with type 2 diabetes. Both drugs belong to the glucagon-like peptide-1 (GLP-1) receptor agonist class of medications. Another drug in the GLP -1 category is Novo Nordisk’s Victoza, the first and only once-daily GLP-1 drug, which received FDA approval earlier this year.
The Bydureon makers’ goal is to submit their reply to the complete response letter by the end of 2011, pending discussions with the FDA. Based on the requirements for additional data, this will likely be considered a Class 2 resubmission requiring a six-month review.
Amylin Pharmaceuticals delayed its scheduled third-quarter earnings release to assess the potential financial impact of the FDA complete response letter regarding Bydureon.
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