FDA panel backs Novo insulin products
FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 8-4 that Novo Nordisk A/S (CSE:NVO; NYSE:NVO) provided sufficient safety and efficacy data to support approval of two 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 Deguldec and 30% Novo Nordisk's NovoLog insulin aspart. Panel members were concerned about the cardiovascular risks of the two 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 eight members who supported the drugs said the trial should be done postapproval. At the meeting, Novo presented a design for a five-year cardiovascular outcomes trial that would enroll 7,500 Type II diabetes patients. ...