Novo Nordisk files for regulatory approval of "faster-acting insulin aspart" in the U.S.

09 Dec, 2015, 08:00 ET from Novo Nordisk

PLAINSBORO, N.J., Dec. 9, 2015 /PRNewswire/ -- Novo Nordisk today announced the submission to the U.S. Food and Drug Administration of a New Drug Application (NDA) for faster-acting insulin aspart, a mealtime insulin developed for the treatment of adults with type 1 and type 2 diabetes.

The filing is based on results from the 'onset' clinical trial program, which involved approximately 2,100 adults with type 1 and type 2 diabetes. The trials evaluated the efficacy and safety of mealtime and after-meal faster-acting insulin aspart to reduce A1C levels and provide postprandial (after-meal) blood sugar control.

"Today's filing of faster-acting insulin aspart is a step forward in strengthening our mealtime insulin offerings for patients who require mealtime blood sugar control," said Todd Hobbs, M.D., U.S. chief medical officer, Novo Nordisk. "Faster-acting insulin aspart underscores our continued commitment to developing new treatment options for these patients. We look forward to working closely with the FDA on the submission and are focused on bringing the next generation of our mealtime insulin to market."

Upon approval, Novo Nordisk intends to make faster-acting insulin aspart available in the pre-filled delivery device FlexTouch® and 10 ml vial.

About Faster-Acting Insulin Aspart
Faster-acting insulin aspart is an investigational mealtime insulin developed by Novo Nordisk for the control of blood sugar levels in adults with type 1 and type 2 diabetes. Faster-acting insulin aspart contains a short-acting insulin and two well-known excipients, a vitamin and an amino acid, to increase the initial absorption rate and an earlier blood sugar lowering effect.

About Diabetes
In the United States, more than 29 million people are affected by diabetes.1 Type 2 diabetes accounts for 90 to 95 percent of all diabetes cases.1 Diabetes is emerging as one of the most serious health problems of our time; the number of Americans with diabetes has tripled over the past 30 years.2

About Novo Nordisk
Novo Nordisk is a global health care company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: hemophilia, growth disorders and obesity. Headquartered in Denmark, Novo Nordisk employs approximately 40,300 people in 75 countries and markets its products in more than 180 countries. For more information, visit
novonordisk-us.com or follow us on Twitter.

References

  1. Centers for Disease Control and Prevention. National Diabetes Statistics Report, 2014. http://www.cdc.gov/diabetes/pubs/statsreport14/national-diabetes-report-web.pdf. Accessed November 8, 2015.
  2. Centers for Disease Control and Prevention. Number (in Millions) of Civilian, Noninstitutionalized Adults with Diagnosed Diabetes, United States, 1980–2011. http://www.cdc.gov/diabetes/statistics/prev/national/figadults.htm. Accessed November 8, 2015.

FlexTouch® is a registered trademark of Novo Nordisk A/S.
Novo Nordisk is a registered trademark of Novo Nordisk A/S.

© 2015 Novo Nordisk     All rights reserved.     USA15NMM01654     December 2015

 

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