FDA Strikes Down the Once a Week Diabetic Medication Bydureon Again
For the second time the FDA has rejected the type 2 diabetic medication Bydureon. The FDA is not convinced that the medication which is time-released (one injection that releases the medication through out the week on an as need basis) is ready for the market.
FDA wants more Clinical Studies
The FDA is requesting more clinical studies on the drug Bydureon more specifically it would like 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.
A Comment from Dr. Kolterman
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.”
Amylin Will Comply with the FDA Request
Despite this setback Amylin Pharmaceuticals will continue to work on the medication and comply with the FDA recommended testing. A shot once a week is certainly better than several injections a day or even one a day.