Novo Nordisk Files for FDA Approval of New Insulin

Novo Nordisk's insulin degludec is injected once daily.

| Oct 15, 2011

A brand new insulin will soon be on pharmacy shelves in the United States if Danish pharmaceutical company Novo Nordisk has its way. The company has filed for approval from the Food and Drug Administration to sell insulin degludec, an original formulation that lasts an extra-long time.

Insulin degludec is injected only once a day. Once under the skin, the dose of insulin is absorbed slowly and consistently, allowing for better nighttime control, according to Novo. Most importantly, test subjects had a low rate of hypoglycemia on the drug.

"We are very excited about being able to file for the approval of insulin degludec and insulin degludec/insulin aspart now also in the US," said Novo Executive Vice President and Chief Science Officer Mads Krogsgaard Thomsen. "This is another significant milestone for Novo Nordisk and for the millions of people with diabetes who require insulin."

As Thomsen mentioned, the company is also applying for approval of a dual formulation of insulin degludec and insulin aspart. In this combination, the long-lasting degludec is accompanied by the short-term aspart. An injection would therefore offer both 24-hour control and a needed bolus after a meal.

Extensive clinical trials have been undertaken to test the safety and efficacy of insulin degludec. The BEGIN and BOOST studies, which wrapped up last year, included nearly 10,000 people with type 1 or type 2 diabetes. Results from the studies showed that the insulin was indeed effective as a 24-hour treatment.

Novo Nordisk, which has a global reach, has spent nearly 90 years in the diabetes care field. Some of its best-known products include Levemir and NovoLog. Novo has also branched into hemophilia care, hormone replacement therapy, and growth hormone therapy.


Source:
http://press.novonordisk-us.com/index.php?s=43&item=304

Click Here To View Or Post Comments

Categories: BEGIN Study, BOOST Study, Diabetes, Diabetes, Food, Hypoglycemia, Injection, Insulin, Insulin Aspart, Insulin Degludec, Novo Nordisk, Type 2 Issues


Take the Diabetes Health Pump Survey
See What's Inside
Read this FREE issue now
For healthcare professionals only
  • What's on the Horizon with Diabetes Research and Therapy
See the entire table of contents here!

You can view the current or previous issues of Diabetes Health online, in their entirety, anytime you want.
Click Here To View

See if you qualify for our free healthcare professional magazines. Click here to start your application for Pre-Diabetes Health, Diabetes Health Pharmacist and Diabetes Health Professional.

Learn More About the Professional Subscription

Free Diabetes Health e-Newsletter

Latest
Popular
Top Rated
Print | Email | Share | Comments (2)

You May Also Be Interested In...


Click Here To View Or Post Comments

Comments 2 comments - Oct 15, 2011

©1991-2014 Diabetes Health | Home | Privacy | Press | Advertising | Help | Contact Us | Donate | Sitemap

Diabetes Health Medical Disclaimer

The information on this site is not intended or implied to be a substitute for professional medical advice, diagnosis or treatment. All content, including text, graphics, images, and information, contained on or available through this website is for general information purposes only. Opinions expressed here are the opinions of writers, contributors, and commentators, and are not necessarily those of Diabetes Health. Never disregard professional medical advice or delay seeking medical treatment because of something you have read on or accessed through this website.