FDA Agrees to Review Novo Nordisk’s Resubmissions of Tresiba, Ryzodeg

Novo Nordisk is moving forward two years after the FDA rejected two insulin therapies, with the agency’s agreement to review Class II resubmissions of its NDAs for Tresiba and Ryzodeg drugs based on an interim analysis of data from a cardiovascular outcomes study.

Novo Nordisk said Tuesday that only a small team within the company has access to the data concerning Tresiba (insulin degludec) and Ryzodeg (insulin degludec/insulin aspart). The trial is expected to be completed in the second half of 2016.

On Feb. 8, 2013, the FDA alerted Novo Nordisk it had rejected NDAs for Tresiba and Ryzodeg, citing the need for a dedicated cardiovascular outcomes trial. — Jonathon Shacat