Seeking Approval of New Diabetes Med

Type 2 diabetes medication albiglutide submitted for FDA approval process

/ Author:  / Reviewed by: Joseph V. Madia, MD

(RxWiki News) For many diabetes patients, diet and exercise alone isn't enough to control blood sugar levels. These patients need medications. And they may need more options. A new diabetes medication is at the start of the approval process.

GlaxoSmithKline has filed an application to the US Food and Drug Administration (FDA) for approval of albiglutide, the company's new once-weekly medication for the treatment of type 2 diabetes.

"Ask your doctor about emerging diabetes treatments."

The application for approval is only the beginning. It could take years before the FDA decides if this medication is safe and effective enough to be used by diabetes patients.

Currently, albiglutide is not approved for diabetes patients anywhere in the world. But GlaxoSmithKline plans to submit a similar application to regulators in the European Union.

Albiglutide is part of a class of injectable medications called GLP-1 agonists. Normally, GLP-1 is made by the gastrointestinal tract during a meal. GLP-1 then helps release the hormone insulin, which controls increases in blood sugar after eating. In people with type 2 diabetes, the release of GLP-1 is reduced or doesn't happen at all.

Albiglutide is a GLP-1 medication taken once a week. Other GLP-1 medications include Victoza (liraglutide), Byetta (exenatide) and Bydureon (exenatide).

According to an article in Reuters, annual sales of albiglutide are forecasted to be around $367 million by 2017. These projected sales are only a modest portion of of the GLP-1 market.

Reviewed by: 
Review Date: 
January 14, 2013
Last Updated:
January 15, 2013