Monday, February 6, 2012

FDA Finally Approves Bydureon

February 6th, 2012 written by Michael O’Leary

Try, try again. After three tries BYDUREON, the once-a-week version of Byetta received FDA approval last Friday, Jan. 27. The approval follows two earlier rejections by the FDA, which each time asked for more data.

BYETTA® (exenatide) was developed by Amylin Pharmeceuticals and Eli Lily. The twice-daily injection drug was the first glucagon-like peptide-1 (GLP-1) receptor agonist to be approved by the FDA for the treatment of type 2 diabetes. GLP-1 stimulates the release of insulin when glucose levels become too high. (Published site)


BYDUREON® combines exenatide, with a technology developed by Alkermes, Inc to provide a sustained release delivery of the drug, which allows once-a-week injections. The drug can be taken alone or with other diabetes medications.

According to Medical News Today, the companies won the FDA’s approval after submitting safety and effectiveness data from the DURATION trial, as well as the clinical safety and effectiveness data supporting the original approval of Byetta.

The DURATION clinical trial compared the effectiveness of BYDUREON with that of Byetta in 295 patients with type 2 diabetes. Participants were randomly assigned to the twice-daily dose of of Byetta or once-weekly BYDUREON and compared for control of blood sugar. After 30 weeks, the data showed that 77 percent of those in the BYDUREON group achieved the HbA1c level of 7 percent or less compared to 61 percent of Byetta group.

Just as important as far as the FDA was concerned, the BYDUREON group did not have any greater risk of low-blood sugar (hypoglycaemia) and had similar reductions in bodyweight as the Byetta group. The average weight loss for the BYDUREON group was about 5 pounds, while the average weight loss for the Byetta group was 3 pounds.

Side effects for both groups included diarrhea, upper respiratory infections and skin reactions at the injection site.

One of the things the FDA was most concerned about is a greater risk of acute pancreatitis, or inflammation of the pancreas that over time can result in scarring of the pancreas and a loss of pancreatic function. Some thyroid tumors have also been reported. This risk showed up after the original approval of Byetta and is now undergoing what the FDA calls, Risk Evaluation and Mitigation Strategy (REMS), requiring the companies to report any adverse events, and to include a warning in the packaging explaining the risks to the pancreas. The approval of BYDUREON will also be subject to the same requirements.

Despite the risks, it is expected that many people with type 2 diabetes will want the convenience of greater blood sugar control with only a once-a-week injections, although the cost may cause some sticker shock. Amylin said the wholesale price of BYDUREON would be $323.44 for a four-week supply.

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