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
