Editor's ChoiceMain Category: Diabetes
Also Included In: Pharma Industry / Biotech Industry;??Regulatory Affairs / Drug Approvals
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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.
Orville G. Kolterman, M.D., senior vice president, chief medical officer, Amylin Pharmaceuticals, said:
We are committed to working closely with the FDA to resolve the issues raised in the complete response letter so that Bydureon can be approved, and we can make this important treatment available to patients with type 2 diabetes as quickly as possible. We remain confident in Bydureon based on the extensive exenatide database, including more than seven years of clinical experience with Byetta, the twice-daily form of exenatide that is available in more than 60 countries worldwide.
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).
Various business media report that shares in Amylin, Alkermes and Lilly have dropped today. Amylin, which has not made a profit since 1992 when it went public, is thought to be the most badly affected by this delay in the medication's route towards approval in the USA. Alkermes will also be affected, but less so than Amylin because is sells other profitable products, such as Risperdal for bipolar disorder treatment - just last week the FDA approved the expanded use of Vivitro for opioid dependence. Eli Lilly may rethink its strategy for growth. Lilly had hoped that the extra income from Bydureon would compensate for its loss of revenue when the patent life of schizophrenia drug Zyprexa expires in 2011.Bad news for one company is sometimes good news for another. Bydureon's delay means Novo Nordisk will now have more elbow room to establish its once-daily diabetes medication Victoza.
Sources: Eli Lilly, FDA
Written by Christian Nordqvist
Copyright: Medical News Today
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