BioCentury
ARTICLE | Clinical News

Ryzodeg insulin degludec/insulin aspart regulatory update

April 13, 2015 7:00 AM UTC

Novo Nordisk said FDA accepted for review 2 resubmitted NDAs for Tresiba insulin degludec and Ryzodeg insulin degludec/insulin aspart to treat Type I and II diabetes. Novo Nordisk said the resubmissions would be considered a Class 2 resubmission but declined to disclose the PDUFA date. The NDAs include an interim analysis of major adverse cardiovascular events (MACE) from the Phase III DEVOTE cardiovascular outcomes trial of Tresiba. In 2013, Novo Nordisk said FDA requested additional CV data from a dedicated CV outcomes trial in the agency’s complete response letter. ...