AMLN believes that the rate of pancreatitis and the more severe hemmorhagic/necrotizing pancreatitis associated with Byetta (1:3000 and less than 1:10,000 respectively) are not higher than the expected rate in the overall patient population. However, the language in the FDA’s August 2008 update implies the FDA’s own data suggests otherwise. LAR once-weekly long acting, has a different pK profile (high variability) and higher levels of antibodies, this makes me think that the FDA might suspect it is causing higher rates of persistent hypoglycemia and pancreatitis and ask for more clinical data. So, in short my answer is yes.
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