Novo Nordisk says U.S. FDA requests more Tresiba, Ryzodeg data

COPENHAGEN Sun Feb 10, 2013 4:08pm EST

COPENHAGEN Feb 10 (Reuters) - Denmark's Novo Nordisk on Sunday said the U.S. Food and Drug Administration (FDA) had requested additional cardiovascular data following additional trials of two new drug applications, Tresiba and Ryzodeg.

The insulin maker said it did not expect to be able to provide the requested data during 2013.

In the letter, the FDA requested additional cardiovascular data from a dedicated-outcomes trial before the review of the New Drug Applications can be completed, Novo said.