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FDA Approves First and Only Weekly Diabetes 2 Shot Therapy in the US

Posted Jan 28 2012 9:46pm

Bydureon took three tries to make it through approval with the FDA.  The active ingredient comes from a synthetic version of saliva from the Gila Monster.  I am image originally from Arizona and I know what those are and way back in 2007 the talk was in the exploration of saliva with lizards.  Bydureon is not insulin and is not for people with diabetes type 1.  Byetta is the non extended version of the drug that has been around for a once a day injection and has been associated with acute pancreatitis, so I would guess the same warnings would apply here as well. 

BYDUREON has been approved with a Risk Evaluation and Mitigation Strategy (REMS) and there are a number of post market requirements to assess the impact of the drug relative to thyroid cancer or heart disease as some rats in the testing phase had those issues. 

Jan. 27 (Bloomberg) -- Amylin Pharmaceuticals Inc. and Alkermes Plc succeeded in their third attempt to gain U.S. clearance for Bydureon, a once-weekly version of Amylin’s diabetes shot.

The Food and Drug Administration approved the drug for adults with image Type 2 diabetes, the agency said today in a letter posted on their website.

Bydureon is a long-acting form of Byetta, a twice-daily injection that San Diego-based Amylin developed with Eli Lilly & Co. in a partnership that ended last year. Amylin lost almost half its market value on Oct. 20, 2010, after the FDA rejected Bydureon for a second time and sought a study on cardiac effects. The companies refiled for approval last year after the trial didn’t tie the drug to dangerous heart-rhythm changes. image

The active ingredient in Byetta and Bydureon, known as exenatide, stimulates pancreas cells to produce insulin when blood sugar is high. It is a synthetic version of a substance found in the saliva of the Gila monster. Bydureon uses technology developed by Alkermes to slowly release exenatide into the bloodstream with one dose a week. The drug won European Commission approval in June.


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