FDA approves Novo Nordisk’s diabetes drugs
pharmafile | September 28, 2015 | News story | Sales and Marketing | FDA, Novo Nordisk, Ryzodeg, Tresiba, diabetes, insulin
The FDA has approved two Novo Nordisk drugs, Tresiba and Ryzodeg, for the treatment of type 2 diabetes in adults.
The approvals come after the FDA reviewed the company’s resubmitted New Drug Applications.
Novo Nordisk expects to launch Tresiba (insulin degludec) in the US during the first quarter of 2016. Tresiba will be available in the FlexTouch device and will be offered in two concentrations enabling maximum doses of 80 units and 160 units per injection, singly.
Tresiba is a once-daily new-generation basal insulin analogue. In ‘treat-to-target’ studies comparing Tresiba to insulin glargine, people using Tresiba achieved similar reduction in long-term blood glucose.
Ryzodeg 70/30 (insulin degludec/insulin aspart) can be administered once or twice daily with any main meal. In a ‘treat-to-target’ study where Ryzodeg 70/30 was compared to Novo Log Mix 70/30, Ryzodeg 70/30 showed equivalent reductions in blood sugar levels.
Novo Nordisk resubmitted its FDA application for Tresiba and Ryzodeg in March, along with new interim safety data requested by the regulator. The FDA agreed to look again at the new package of data in April.
The FDA had initially rejected the company’s original submission for Tresiba (insulin degludec) and Ryzodeq (insulin degludec/insulin aspart) in 2013. It issued a Complete Response Letter to the Danish firm demanding more data on cardiovascular safety from a dedicated cardiovascular outcomes trial before it could complete its review of the applications.
Lars Rebien Sørensen, president and chief executive of Novo Nordisk says: “We are very happy with FDA’s decision to approve Tresiba and Ryzodeg 70/30 as we believe these products offer significant benefits and important treatment options for people with type 1 and type 2 diabetes. The approvals mark an important milestone for Novo Nordisk and we look forward to making Tresiba available for people in the US.”
In a separate regulatory move, Novo Nordisk also submitted a New Drug Application for Xultophy, the first once-daily single-injection combination of Tresiba and Victoza (liraglutide), to the FDA. The submission is expected to be reviewed under US FDA’s Prescription Drug User Fee Act V.
Yasmita Kumar
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