FDA Approves Two Novo Nordisk Diabetes Drugs
Novo Nordisk expects to launch its once daily insulin Tresiba in the first quarter of 2016, following FDA approval of that and another diabetes treatment in September.
The approvals mark a successful turnaround from the February 2013 rejection of NDAs for Tresiba (degludec) and Ryzodeg 70/30 (degludec and insulin aspart) based on the need for a dedicated cardiovascular outcomes trial.
In March, the drugmaker filed Class II resubmissions of the NDAs following completion of an interim analysis of the cardiovascular outcomes trial for Tresiba. The trial is slated for completion in the second half of 2016.
The approvals are based on clinical trials showing that Tresiba and Ryzodeg reduce HbA1c, or glycated hemoglobin, comparable to other previously approved long-acting or premixed insulins. Both drugs are indicated to improve the control of blood sugar in adults with type 1 and 2 diabetes. — Jonathon Shacat