The U.S. FDA issued a Complete Response Letter regarding the New Drug Applications for Tresiba (insulin degludec) and Ryzodeg (insulin degludec/insulin aspart) informing Novo Nordisk that an application cannot be approved in its current form. Read more
The European Commission has granted Novo Nordisk marketing authorizations for Tresiba (insulin degludec) and Ryzodeg (insulin degludec/insulin aspart) for the treatment of diabetes in adults in 27 European Union member states. Read more
The Japanese Ministry of Health, Labor and Welfare has approved Novo Nordisk’s new combination insulin, Ryzodeg, for the treatment of diabetes.
Ryzodeg is a soluble formulation of Tresiba (insulin degludec), a once-daily new-generation basal insulin analogue with an ultra-long duration of action, and NovoRapid (insulin aspart which in the U.S. is marketed under the brand name NovoLog). Ryzodeg can be administered once or twice daily with the main meal(s). Read more
Novo Nordisk has announced the initial results of the Diabetes Attitudes, Wishes and Needs 2 (DAWN2) study. The DAWN2 study is the largest study of its kind, conducted across 17 countries and 4 continents, into the psychosocial aspects of management of diabetes. Read more
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. Read more
A homerun for Novo Nordisk, but a strike-out for Jessica Apple. I spent the weekend in Copenhagen taking part in Novo Nordisk’s DAWN2 Global Results Meeting. Before I say anything else, I want to note that I was honored … Read more
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, Read more
According to the GAPP2™ (Global Attitudes of Patients and Physicians) survey, funded by Novo Nordisk and presented today at the Annual Meeting of the European Association for the Study of Diabetes (EASD), four out of five (80%) people with type 2 diabetes have experienced self-treated hypoglycemia… Read more
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).
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. Read more