Cookie policy: This site uses cookies (small files stored on your computer) to simplify and improve your experience of this website. Cookies are small text files stored on the device you are using to access this website. For more information please take a look at our terms and conditions. Some parts of the site may not work properly if you choose not to accept cookies.

Join

Subscribe or Register

Existing user? Login

US Food and Drug Administration

US FDA approves two injectable diabetes treatments

Two new drugs marketed by Danish pharmaceutical company Novo Nordisk (flag with logo pictured) to improve blood sugar control in patients with type 1 and type 2 diabetes have been given marketing authority in the US

Source: Novo Nordisk

Two Novo Nordisk diabetes treatments gain approval from the US Food and Drug Administration

Two drugs that improve blood sugar control in patients with type 1 and type 2 diabetes have been given marketing authority in the United States. 

The Food and Drug Administration (FDA) approved Novo Nordisk’s insulin degludec injection (Tresiba) and insulin degludec/insulin aspart injection (Ryzodeg 70/30) on 25 September 2015.

The decision to approve insulin degludec injection follows the results of clinical trials involving 1,102 patients with type 1 diabetes and 2,702 patients with type 2 diabetes when the product was used in combination with mealtime insulin. The long-lasting insulin brought about a reduction in haemoglobin A1c or glycosylated haemoglobin in patients who had inadequate blood sugar control. 

The decision to approve insulin degludec/insulin aspart injection, when used in conjunction with mealtime insulin, was based on the results of clinical trials involving 362 type 1 and 998 type 2 patients. The drug produced the same reduction in HbA1c levels achieved with other approved long-acting or pre-mixed insulin, the FDA said. 

“Long-acting insulins play an essential role in the treatment of patients with type 1 diabetes and in patients with type 2 diabetes with advanced disease,” says Jean-Marc Guettier, director of the division of metabolism and endocrinology products in the FDA’s Center for Drug Evaluation and Research. 

The European Medicines Agency gave both products a licence in January 2013.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2015.20069450

Have your say

For commenting, please login or register as a user and agree to our Community Guidelines. You will be re-directed back to this page where you will have the ability to comment.

Recommended from Pharmaceutical Press

Search an extensive range of the world’s most trusted resources

Powered by MedicinesComplete
  • Print
  • Share
  • Comment
  • Save
  • Print Friendly Version of this pagePrint Get a PDF version of this webpagePDF

Newsletter Sign-up

Want to keep up with the latest news, comment and CPD articles in pharmacy and science? Subscribe to our free alerts.