BioCentury
ARTICLE | Clinical News

Ryzodeg insulin degludec/insulin aspart regulatory update

November 12, 2012 8:00 AM UTC

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 benefits of reduced hypoglycemia and the potential for long-term dosing of Tresiba outweighed the risks.

The panel unanimously backed a cardiovascular outcomes trial of both drugs, but the 8 members who supported the drugs said the trial should be done postapproval. At the meeting, Novo presented a design for a 5-year cardiovascular outcomes trial that would enroll 7,500 Type II diabetes patients. ...