12:00 AM
Nov 12, 2012
 |  BC Week In Review  |  Clinical News  |  Regulatory

Ryzodeg insulin degludec/insulin aspart regulatory update

FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 8-4 that Novo Nordisk provided sufficient safety and efficacy data to support approval of 2 products for Type I and II diabetes. The products were Tresiba insulin Degludec, a long-acting insulin analog, and Ryzodeg, a combination of 70% insulin Degludec and 30% Novo Nordisk's NovoLog insulin aspart. Panel members were concerned about the cardiovascular risks of the 2 therapeutics, but felt the...

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