Tresiba | Page 2 of 3

Degludec, Novo Nordisk’s New Insulin, On Its Way To FDA Approval

The Endocrinologic and Metabolic Drugs Advisory Committee of the United States Food and Drug Administration (FDA) completed its meeting regarding the New Drug Applications (NDA) for Novo Nordisk's insulin degludec (to be marketed under the name Tresiba) and insulin degludec/insulin aspart.

EU Panel Backs Novo Nordisk’s Tresiba

The Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) adopted positive opinions, recommending marketing authorizations, for Novo Nordisk's new insulin Tresiba and insulin Ryzodeg for the treatment of diabetes mellitus in adults. Tresiba , the intended brand name for insulin degludec, is a new generation of once-daily basal insulin. In "treat-to-target? studies supporting the new drug application, where Tresiba was compared to insulin glargine,

Novo Nordisk’s New Ultra-Long-Acting Insulin Degludec Shows Lower Rate of Hypoglycemia

Data from two new studies shows patients with type 2 diabetes starting insulin therapy had a 43% lower rate of night-time hypoglycemia when using degludec, Novo Nordisk’s ultra-long-acting insulin, compared with those using insulin glargine (Lantus).

Novo Nordisk’s Ultra-Long Acting Insulin, Tresiba, Approved in Japan

The Japanese Ministry of Health, Labour and Welfare has approved Novo Nordisk's ultra-long acting insulin, insulin degludec, for treatment of diabetes. Insulin degludec, marketed globally under the name Tresiba, is a new generation of once-daily basal insulin, which has been discovered and developed by Novo Nordisk.

FDA Extends Review Period of Novo Nordisk’s Ultra-Long-Acting Insulins

The U.S. FDA has informed Novo Nordisk that a three-month extension period was required in order to complete its regulatory review of the new drug applications (NDA) for the ultra-long-acting insulins degludec and insulin degludec/insulin aspart...

Ultra Long Acting Insulin Degludec Reduces Nocturnal Hypoglycemia, New Studies Show

Two new phase 3 studies published in The Lancet show that ultra long acting insulin, Degludec, an investigational compound from Novo Nordisk, significantly reduces the rates of nocturnal hypoglycemia by 25%, compared to insulin glargine. The two studies included in total 1,635 participants and investigated insulin degludec compared to insulin...

New Studies Show Novo Nordisk’s Combination Insulin Reduces Hypoglycemia

A study released by Novo Nordisk at the International Diabetes Federation (IDF) 21st World Diabetes Congress in Dubai has found that the combination insulin degludec/insulin aspart, currently being developed, significantly reduced hypoglycemia in type 1 diabetes and type 2 diabetes patients...

Insulin Like A String of Pearls: How Degludec Works

There was one thing about Degludec that caught my attention, and after speaking to Dr. Alan Moses of Novo Nordisk about it, I now believe Degludec is awesome.

Novo Nordisk Requests FDA Approval for Ultra-Long-Acting Insulin Degludec

Novo Nordisk filed two new drug applications for the approval of ultra-long-acting insulin degludec and the co-formulation, insulin degludec/insulin aspart (DegludecPlus) by the U.S. Food and Drug Administration. These new insulin analogs have been developed for the treatment of people with type 1 and type 2 diabetes.

Novo Nordisk’s New Ultra-Long-Acting Insulin Proves Effective for Treatment of Type 2 Diabetes

Novo Nordisk's ultra-long-acting insulin degludec, an investigational basal insulin being developed, showed significant blood sugar reductions in patients with type 2 diabetes even when doses were given once-daily up to 40 hours apart, according to data presented today at the European Association for the Study of Diabetes (EASD) in Lisbon...