Novo's CV outcomes trial to start 'within a year'

Novo Nordisk A/S (CSE:NVO; NYSE:NVO) disclosed in its 1Q13 earnings on Wednesday that it plans to start "within a year" the FDA-requested CV outcomes trial of Tresiba insulin degludec and Ryzodeg insulin degludec/insulin aspart. In a February complete response letter for the diabetes products, FDA said data from the trial would be required prior to completing the review of the NDAs, which were under review to treat Type I and II diabetes in adults. The company said data for an interim analysis could be the basis for a resubmission and are expected two or three years after the trial starts. Tresiba is a long-acting insulin analog, and Ryzodeg is a combination of 70% Tresiba and 30% Novo's NovoRapid insulin aspart (see BioCentury, Feb. 18). ...