Zachary Bloomgarden, MD: What Victoza approval means for Byetta LAR
February 7, 2010
The HCC interviewed diabetes specialist Zachary Bloomgarden, MD about his thoughts on the newly approved GLP-1 Victoza and what it might mean for the eventual label on Byetta LAR.
The HCC Q1: Overall, was the label for Victoza better or worse than you expected?
Bloomgarden: I’m concerned at how to counsel other physicians - and my patients - on the thyroid findings. Ideally, some further guidance would have been provided beyond “if there is a mass in the neck look into it.” The pancreatitis issue may be real, but does not require a change in the approach already used for Byetta, that with any non-trivial/expected GI symptoms patients should not take the drug until they have contacted their doctor. On the pro side, the very impressive glycemic benefit, compared with multiple other agents, the weight loss, and the rather good overall tolerability are clearly expressed.
The HCC Q2: Are the pancreatitis sections expressing a legitimate concern in your view?
Bloomgarden: Yes, as above
The HCC Q3: What does this mean for Byetta LAR regarding pancreatitis and other safety issues listed in the Victoza label?
Bloomgarden: I don’t see how Byetta LAR will not have pancreatitis cautions and I want to make sure that they have conducted sufficient human calcitonin measurements to address the concern as to whether or not there is an effect (remember with Victoza it is only seen in ~2% vs. ~1%, so large numbers of patients need to be tested).
The HCC Q4: If Byetta LAR is approved, how will it compete in pros and cons to Victoza?
Bloomgarden: Pro-Byetta is weekly rather than daily, pro-Victoza is probably a much easier injection not requiring the large needle, the reconstitution, etc. Side effects to my mind will be the thyroid issue as above, whether it is or is not will be a big deal.
Zachary T. Bloomgarden, MD
Editor, the Journal of Diabetes
http://www3.interscience.wiley.com/journal/118902543/home
———————-
Clinical Professor
Department of Medicine
Mount Sinai School of Medicine
Diabetes, Endocrinology, Internal medicine, Mt Sinai NYC | apples49 | 
February 7, 2010 3:01 pm
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