Amylin's Once-Weekly Diabetes Injection Finally Wins FDA Approval

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Main Category: Diabetes
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 29 Jan 2012 - 0:00 PST

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On Friday, the US Food and Drug Administration finally approved Amylin Pharmaceutical's diabetes drug Bydureon, which provides glycemic control for diabetes type 2 in a once-weekly injection. The approval follows two earlier rejections in 2010, when the FDA asked the company to go back and carry out a new trial of the drug's effect on heart rhythm.

The company describes Bydureon (exenatide extended-release for injectable suspension) as the first of its kind. It is a once-a- week version of Byetta, the company's 7-year-old diabetes drug that has to be injected twice a day.

The drug, a glucagon-like peptide-1 (GLP-1) receptor agonist, is approved for use alongside diet and exercise to improve blood sugar control in adults with type 2 diabetes. The company says it will be available in pharmacies throughout the US in February.

Dr John Buse is a professor of medicine, the director of the Diabetes Care Center, and chief of the Division of Endocrinology at the University of North Carolina School of Medicine in Chapel Hill. He said in a statement that with Bydureon, doctors and their patients now have the option of a treatment that offers continuous control of blood sugar with just one dose per week:

"New treatment options are essential for the millions of adults with type 2 diabetes who continue to struggle to achieve optimal blood sugar control" said Buse.

To get the approval, the company submitted safety and efficacy data from the DURATION clinical trial of Bydureon, backed by clinical experience with twice-daily injections of Byetta (exenatide).

Byetta is used in nearly 80 countries worldwide. It has been available in the US since June 2005.

Bydureon uses Alkermes' proprietary technology to provide controlled release of exenatide over the course of a week.

In the DURATION trial, Bydureon was tested head to head against Byetta for 24 weeks. The results showed that patients taking Bydureon experienced a "a statistically superior reduction in A1C of 1.6 percentage points from baseline, compared to a reduction of 0.9 percentage points" for those taking Byetta, said Amylin. (A1C is a measure of average blood sugar over three months.)

By the end of the study, both groups achieved statistically signficant weight loss, a secondary endpoint of the trial (average loss was 5.1 pounds, 2.3 kg, for those on Bydureon, and 3.0 pounds, 1.4 kg, for those on Byetta).

The most common side effects in both groups was nausea, which was reported less frequently by the Bydureon users (14%) than the Byetta users (35%).

Other common side effects for the Bydureon group were diarrhea, upper respiratory tract infection and injection site nodules. There were no major hypoglycemic events, according to Amylin.

The new drug has been approved with a Risk Evaluation and Mitigation Strategy (REMS) to make sure the benefits exceed the risk of acute pancreatitis and the potential risk of medullary thyroid carcinoma.

Based on postmarketing data, exenatide has been linked acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. And in animal studies, Bydureon caused rats to develop thyroid tumors, some of the cancerous.

Amylin said it will also be fulfilling "a number of post-marketing requirements to further assess the impact of BYDUREON on medullary thyroid cancer and cardiovascular disease".

More information:

Full Boxed Warning and other safety information is available at the company's website for the drug http://www.bydureon.com/.

For FDA information on Bydureon go to the Drugs@FDA webpage and enter the name "Bydureon" into the search box.

Written by Catharine Paddock PhD


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