February 11, 2013

FDA Asks for More Study of Degludec

Good friend of the blog Scott Strumello sent me a link to Pharmalot that says the FDA is looking for more studies and will reject the application to market insulin degludec pending those studies. http://www.pharmalot.com/2013/02/sticking-point-fda-rejects-novo-nordisk-insulin/

I applaud safety and scrutiny on cardio risks is part of safety. However it is not the only safety issues with insulin.

I wonder if the current basal insulins would pass the same level of safety and long term risk for cardio issues. The FDA panel IMHO seemed any potential benefits of the insulin the benefits saying there was already an approved drug so we can be tougher on cardio here. One benefit seemed to be fewer hypos. Hypos have risks and the benefit of a reduction of those risks appeared to me, as non physician lay observer who clearly could be missing the mark, to be brushed over.

It is hard to balance all that out but there should be a conversation about it.

My comments at the hearing are here:

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