FDA requires more data before approving once-weekly exenatide
The FDA has decided not to approve the weekly, extended-release formulation of exenatide until additional safety and efficacy data are submitted.
The decision came this week before the Prescription Drug User Fee Act (PDUFA) action data of Oct. 22, 2010, for once-weekly exenatide (Bydureon; Eli Lilly, Amylin and Alkermes).
The FDA issued a complete response letter regarding the New Drug Application, requesting a thorough QT study with exposures of exenatide higher than typical therapeutic levels. The thorough QT protocol will be agreed to by the FDA prior to study initiation, according to a company press release. The agency also requested results of the DURATION-5 study to evaluate the safety and efficacy of the drug.
The companies’ goal is to submit a reply to the complete response letter by the end of 2011, pending discussions with the FDA.
The New Drug Application was submitted in May 2009. It is based on data from the DURATION-1 head-to-head clinical study, DURATION-2 safety data, and more than 7 years of clinical experience, according to the companies.
“We remain confident in Bydureon based on the extensive exenatide database, including more than 7 years of clinical experience with Byetta, the twice-daily form of exenatide that is available in more than 60 countries worldwide,” Orville G. Kolterman, MD, senior vice president and chief medical officer of Amylin Pharmaceuticals, said in the company release.
The investigational, extended-release medication for type 2 diabetes is designed to deliver continuous therapeutic levels in a single weekly dose. It belongs to the glucagon-like peptide-1 receptor agonist class of medications.
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