NOVO: FDA extends degludec and insulin degludec/insulin aspart review period

Novo Nordisk (OMX: NOVO B) said this morning that the U.S. FDA has extended the regulatory review period for Novo’s new drug applications (NDA) for the two insulins degludec and insulin degludec/insulin aspart intended for the treatment of type 1 and type 2 diabetes. The agency says it requires more time to complete its review after previously asking for more data and analyses. Novo says it has submitted plenty and the agency considers those a major amendment(s) to the NDA(s).

Insuling deglugec is a once-daily ultra-long acting basal insulin analogue and Insulin degludec/insulin aspart contains the former in a formulation with a boost of insuling aspart, combining the long-acting insulin and rapid acting insulin. There are also pending applications in Europe for two products. No request for additional clinical trial has been made. The new action date is 29th of October 2012.