The bid to get Byetta(exenatide) once-weekly version for diabetes treatment approval from the FDA (Food and Drug Administration) has failed for a second time Amylin Pharmaceuticals, Inc., Eli Lilly and Alkermes, Inc. announced. The plan was to sell the once-weekly version of exenatide under the brand name Bydureon. In a response letter, the FDA explained that it wanted a comprehensive study on the medication's effect on QT interval at higher than normally given doses, it also wants to examine the DURATION-5 trials' efficacy, and the labeling of its safety and effectiveness - the trial compared exenatide's extended release formulation (Bydureon) to twice-daily injectable Byetta, which is currently available.
Eli Lilly said today that the iQT protocol will be worked out with the FDA before starting the study. It aims to submit a reply to the complete response letter by the end of next year. Experts in the pharmaceutical industry say that this "surprise"delay will probably make the three companies have another close look at their short-term strategies. Bydureon is an investigational, extended-release injectable drug for patients with diabetes type 2; it is designed to deliver continuous therapeutic levels of exenatide with just one dose per week. Byetta, which was approved in the USA in June 2005 as a twice-daily injection to improve glycemic control in diabetes type 2 patients, is also available in over 60 countries. Both brands belong to the glucagon-like peptide receptor agonist class of drugs.
Bydureon's New Drug Application (NDA) was submitted in May 2009. The submission is based on information included in the DURATION-1 clinical trial, a head-to-head study, as well as data on Byetta since it appeared on the market.
Over 24 million US citizens have been diagnosed with diabetes. The World Health Organization (WHO) estimates that approximately 285 million adults globally suffer from diabetes, of whom between 90% and 95% have diabetes type 2. CDC (Centers for Disease Control and Prevention) data indicates that the majority of people with diabetes do not attain their target blood sugar levels. 55% of individuals with diabetes type 2 are obese and 85% are overweight (including obese).
Eli Lilly said today that the iQT protocol will be worked out with the FDA before starting the study. It aims to submit a reply to the complete response letter by the end of next year. Experts in the pharmaceutical industry say that this "surprise"delay will probably make the three companies have another close look at their short-term strategies. Bydureon is an investigational, extended-release injectable drug for patients with diabetes type 2; it is designed to deliver continuous therapeutic levels of exenatide with just one dose per week. Byetta, which was approved in the USA in June 2005 as a twice-daily injection to improve glycemic control in diabetes type 2 patients, is also available in over 60 countries. Both brands belong to the glucagon-like peptide receptor agonist class of drugs.
Bydureon's New Drug Application (NDA) was submitted in May 2009. The submission is based on information included in the DURATION-1 clinical trial, a head-to-head study, as well as data on Byetta since it appeared on the market.
Over 24 million US citizens have been diagnosed with diabetes. The World Health Organization (WHO) estimates that approximately 285 million adults globally suffer from diabetes, of whom between 90% and 95% have diabetes type 2. CDC (Centers for Disease Control and Prevention) data indicates that the majority of people with diabetes do not attain their target blood sugar levels. 55% of individuals with diabetes type 2 are obese and 85% are overweight (including obese).
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