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RN,MSN,CDE,FAADE,CNS
FDA approved Bydureon, once weekly exenatide
Section:  Nursing
NY Times reported today (Jan,30,2012) that the FDA has approved Bydureon.
 
"Amylin Pharmaceuticals and Alkermes' Bydureon, or exenatide, was approved by the FDA as a once-weekly treatment for type 2 diabetes. The glucagonlike peptide-1 receptor agonist costs about $4,200 a year. Amylin is conducting an FDA-requested trial to determine whether Bydureon heightens the risk of heart attacks, thyroid cancer and pancreatitis"
 
"Despite the less frequent injections, Bydureon will not automatically be preferred over Victoza. That is in part because there is some data from one of Amylin’s own trials suggesting Bydureon is slightly less effective in controlling blood sugar than Victoza. Also, it is more cumbersome for a patient to prepare Bydureon for each injection and the needle used is larger than for Victoza. "

"Amylin said the wholesale price of Bydureon would be $323.44 for four doses, or about $4,200 a year. That is between the roughly $3,400 for the low dose of Victoza and $5,000 for the high dose, said Mark Schoenebaum, an analyst at the ISI Group."

"The F.D.A. is requiring Amylin to conduct a clinical trial, which has begun, to assess whether Bydureon increases the risk of heart attacks and other cardiovascular problems. The same trial will also look at whether the drug increases the risk for thyroid cancer, pancreatitis and other health problems. "

Take a look at the packaging and the complex procedure needed to preparing Bydureon for injection. From the looks of things, I ,personally ,don't think it will be a big seller. www.medicines.ie/pdfviewer.aspx?isAttachment=true&documentid=15149

MEMBER COMMENTS
Re: FDA approved Bydureon, once weekly exenatide

Technically, this does not seem that different than the prepartion of a glucagon injection.  I suspect that it will be more hampered by not being any better than Victoza and costing more.  When I took Victoza, it was still on the brand drug list and had not moved to a preferred drug.  It cost me $200/month and given that it didn't really do anything for me, it was not very cost effective.  Bydureon seems like it will be even more expensive.  Bydureon will no doubt go through the same cycle and until the insurance companies have some evidence that it is more effective than Victoza they are going to be less than excited about moving it to a preferred status.