IDegLira is a combination of Tresiba (insulin degludec), a once-daily basal insulin analogue with an ultra-long duration of action, and Victoza (liraglutide), the once-daily human GLP-1 analogue for the treatment of type 2 diabetes.
Category: Insulin
Sanofi announced the results from the EDITION II study showing that investigational new U300 insulin demonstrated similar blood sugar control as Lantus insulin with 23% fewer night-time lows...
MannKind Corporation has resubmitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the marketing and sale of AFREZZA (insulin human [rDNA origin]) Inhalation Powder with an indication to improve glycemic control in adults with type 1 or type 2 diabetes.
MannKind Corporation has announced that it has positive preliminary results from two Phase 3 clinical studies of Afrezza, inhaled ultra rapid-acting mealtime insulin.
Oramed Pharmaceuticals Inc., a developer of oral drug delivery systems, announced today that the United States Food and Drug Administration…
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.
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.
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).
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.
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,