Diabetes Drugs Tresiba, Ryzodeg Finally Reach FDA Finish Line

Novo Nordisk

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(RTTNews) - Novo Nordisk's (NVO) diabetes drugs Tresiba and Ryzodeg 70/30 finally got the much awaited approval of FDA on Friday.

Tresiba is a once-daily new-generation basal insulin analogue with a half-life of 25 hours and a duration of action of at least 42 hours. Tresiba is expected to be launched in the U.S. during the first quarter of 2016. Tresiba has already been launched in 30 countries.

Ryzodeg 70/30 contains insulin degludec in a soluble co-formulation with insulin aspart, and can be administered once or twice daily with any main meal.

The New Drug Applications for Tresiba and Ryzodeg were turned down by the FDA in February 2013, and the company was asked to conduct a dedicated cardiovascular outcomes trial before the products could be approved.

Accordingly, the company initiated a cardiovascular outcomes trial for Tresiba, dubbed DEVOTE, in October 2013, and the required number of major adverse cardiovascular events (MACE) for the prespecified interim analysis were accumulated by the end of January 2015.

The company resubmitted the New Drug Applications of Tresiba and Ryzodeg to the FDA in April of this year, which were accepted for review as Class II resubmissions.

Commenting on the FDA approval, Lars Rebien Sørensen, president and chief executive officer of Novo Nordisk said, "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".

NVO closed Friday's trading at $54.93, down 0.18%. In after hours, the stock was up 5.57% at $57.99.