The US Food and Drug Administration (FDA) has delayed a decision on the approval of Novo Nordisk's long-acting insulins by three months, citing the need for further data clarification and analyses.
Both insulin degludec and insulin degludec/insulin aspart were submitted by the Danish pharma company for the treatment of type 1 and type 2 diabetes in September, 2011, with the new review completion date now set at October 29, 2012.
In response to the FDA's request, Novo said it has “submitted a substantial amount of additional data” that the agency has considered as major amendments to the new drug applications for both products.
However, it is only additional information from current trials that has been requested, and Novo will not have to complete additional clinical trials as it stands.
Novo has hopes for insulin delgudec as a once-daily, ultra-long-acting basal insulin analogue that has been shown to be effective even when injected at varying times of day in patients with type 2 diabetes.
Insulin degludec/insulin aspart is a combined product that contains insulin degludec in a formulation with a bolus boost of Novo's NovoRapid (NovoLog in the US) to provide further glucose control.
If approved, both products would be direct competitors to Sanofi's Lantus (insulin glargine), which is currently only approved to be taken once daily at the same time each day, potentially making Novo's insulins more desirable for patients unable to stick to an injection routine.
Both insulin degludec and insulin degludec/insulin apart are also current under review by the European Medicines Agency (EMA), and additional applications have been submitted in several other countries including Japan, Canada and Switzerland.