Drug makers back Bydureon with FDA reply letter
In a response to the FDA’s resubmittal of a complete response letter regarding Bydureon, a weekly exenatide injection indicated to treat type 2 diabetes, the drug's makers Amylin Pharmaceuticals, Eli Lilly and Alkermes said that they have submitted a reply letter and expect to receive an updated Prescription Drug User Free Act (PDUFA) action date from the agency within the next two weeks.
According to the companies, the reply had additional data including the results from the completed QT (tQT) study, which showed that exenatide, at and above therapeutic levels, did not prolong the corrected QT intervention in healthy patients. Additionally, the letter also included results from the DURATION-5 study, which compared Bydureon to Byetta (exenatide, Amylin and Eli Lilly).
"We worked expeditiously to complete the requested tQT study and consulted with the FDA throughout the process," said Christian Weyer, MD, senior vice president of research and development for San Diego-based Amylin. "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, a once-weekly formula that contains the active ingredient in Byetta, which has been approved in the U.S. since June 2005. Byetta was the first glucagon-like peptide-1 (GLP-1) receptor agonist to become approved by the FDA to treat type 2 diabetes.
The drug’s new drug application was submitted in May 2009 and was based on safety and efficacy data from the DURATION program. Bydureon received European approval in June. The companies expect the drug to be available in other European countries as soon as possible.
However, since then, Byetta has been linked to acute pancreatitis and is contraindicated for patients with renal impairment.
The companies said that the investigational drug will more than likely be classified as a Class II resubmission by the FDA, which would require up to six months for review.
According to the companies, the reply had additional data including the results from the completed QT (tQT) study, which showed that exenatide, at and above therapeutic levels, did not prolong the corrected QT intervention in healthy patients. Additionally, the letter also included results from the DURATION-5 study, which compared Bydureon to Byetta (exenatide, Amylin and Eli Lilly).
"We worked expeditiously to complete the requested tQT study and consulted with the FDA throughout the process," said Christian Weyer, MD, senior vice president of research and development for San Diego-based Amylin. "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, a once-weekly formula that contains the active ingredient in Byetta, which has been approved in the U.S. since June 2005. Byetta was the first glucagon-like peptide-1 (GLP-1) receptor agonist to become approved by the FDA to treat type 2 diabetes.
The drug’s new drug application was submitted in May 2009 and was based on safety and efficacy data from the DURATION program. Bydureon received European approval in June. The companies expect the drug to be available in other European countries as soon as possible.
However, since then, Byetta has been linked to acute pancreatitis and is contraindicated for patients with renal impairment.
The companies said that the investigational drug will more than likely be classified as a Class II resubmission by the FDA, which would require up to six months for review.