Novo Nordisk Files for Regulatory Approval of the co-formulation insulin degludec/insulin aspart in Japan
Copenhagen, Denmark - Novo Nordisk today announced the submission to the Japanese Pharmaceuticals and Medical Devices Agency, PMDA, of a new drug application for the approval of insulin degludec/insulin aspart for treatment of type 1 and type 2 diabetes. Insulin degludec/insulin aspart is the first and only soluble insulin co-formulation of two insulins – comprised of the ultra-long-acting insulin degludec and the rapid-acting insulin, NovoRapid®.
“We are very excited about having filed for regulatory approval in Japan of both insulin degludec, in December 2011, and now also of insulin degludec/insulin aspart”, said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. “These new-generation insulins have the potential to improve treatment outcomes for people with diabetes”.