On September 25, 2015, the U.S. Food and Drug Administration approved Tresiba (insulin degludec injection) and Ryzodeg 70/30 (insulin degludec /insulin aspart injection) to improve blood sugar (glucose) control in adults with diabetes mellitus, after review of the class II resubmissions of the New Drug Applications (NDAs). Earlier in 2013, FDA had rejected approval of these two drugs because of concerns over cardiovascular outcomes. On 26 March 2015, Novo Nordisk announced the decision to submit the class II resubmissions of the NDAs following the completion of the interim analysis of the cardiovascular outcomes trial for insulin degludec, DEVOTE.
Insulin Degludec: The insulin degludec drug product is a solution for subcutaneous injection. The drug is intended to cover basal insulin requirements in patients with T1DM and T2DM. The drug substance in insulin degludec is an analogue of…
