GSK aks for FDA approval of weekly injectable diabetes drug

Kathleen Blanchard's picture
GSK asks for FDA approval for diabetes drug albiglutide
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The drug manufacturer Glaxo Smith Kline (GSK) released news two days ago that they are asking the FDA for regulatory approval for the injectable diabetes drug albiglutide that can be taken once a week.

The drug is given under the skin or subcutaneously and is in the same class of anti-diabetic medication as Victoza, Byetta and Bydureon.

The drug doesn't have any special implications for patients with type 2 diabetes yet, because it will take years before it is approved.

Albiglutide is a GLP-1 receptor agonist that treats diabetes by lowering blood sugar levels, systolic blood pressure and aiding weight loss.

GlP-1 agonists are often prescribed or patients when other drugs and lifestyle modifications fail.

The approach is known as Incretin grouped therapy that includes both dipeptidyl peptidase-4 (DPP-4) inhibitors and glucagon-like polypeptide-1 (GLP-1) receptor agonists.

DPP-4 inhibitors are taken by mouth once a day.

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Incretin is a hormone that controls insulin production in the pancreas. GLP -1 medications taken for type 2 diabetes help the body produce more insulin after eating, making the therapies appealing, albeit expensive.

GLP-1 is naturally made in the body and is a type of incretin, but only lasts for a few minutes. The goal of treatment with GLP-1 agonists is to prolong its activity. The medications are often combined with other drugs to treat diabetes.

The drug also slows emptying of the stomach so patients feel fuller longer. Slower emptying also means lower glucose levels after a meal.

A major advantage of the drugs is that they don’t cause hypoglycemia or low blood sugar.

GSK tested albiglutide for the treatment of adults with type II diabetes in the phase III 52-week Harmony 8 study; pitting the drug against Merck & Co.’s DPP-4 inhibitor Januvia (sitagliptin) patients who also had kidney impairment.

Last year it was announced that albiglutide failed to match Novo’s Victoza for lowering hemoglobin A1C levels and for weight loss. Other findings from the study were fewer side effects of nausea and vomiting with the GSK diabetes drug, compared to Victoza. The company is also planning on filing
a regulatory application in the European Union (EU) in early 2013.

Reference:
GSK press release
January 14, 2013

Image credit: PHIL.CDC.gov

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