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SOURCE Novo Nordisk
PLAINSBORO, N.J., Sept. 29, 2017 /PRNewswire/ -- Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) approved Fiasp® (insulin aspart injection) 100 Units/mL, a fast-acting mealtime insulin indicated to improve glycemic control in adults with type 1 and type 2 diabetes.1 Fiasp® can be dosed at the beginning of a meal or within 20 minutes after starting a meal. Fiasp® is a new formulation of NovoLog®, in which the addition of niacinamide (vitamin B3) helps to increase the speed of the initial insulin absorption, resulting in an onset of appearance in the blood in approximately 2.5 minutes.2 Fiasp® will be available in a pre-filled delivery device FlexTouch® pen and a 10 mL vial.1
Many adults with type 1 and type 2 diabetes struggle with blood sugar control after meals. The result of this has led to many people with diabetes not achieving their target A1C.
"With Fiasp®, we've built on the insulin aspart molecule to create a new treatment option to help patients meet their post-meal blood sugar target," said Bruce Bode, MD FACE, President of Atlanta Diabetes Associates and Associate Professor at Emory University School of Medicine. "The intention of rapid acting insulin therapy is to mimic, as much as possible, the natural physiological insulin response that occurs after meals, a process that is important for optimal A1C management."
Fiasp® will launch at the same list price as NovoLog® and will be offered with a Savings Card program for eligible patients with commercial insurance to reduce co-pays. Fiasp® will also be available to eligible patients through the Novo Nordisk Patient Assistance Program. Patients and caregivers can obtain more information and access to the Novo Nordisk Patient Assistance Program by calling toll free at 866-310-7549.
The approval of Fiasp® is based on results from the onset phase 3a clinical development program. The clinical trials enrolled more than 2,000 adults with type 1 and type 2 diabetes to evaluate the efficacy and safety of Fiasp® administered both at mealtime and after starting a meal. Data from the trials showed that Fiasp® demonstrated a reduction in A1C in adults with type 1 and type 2 diabetes.1 Common adverse reactions, excluding hypoglycemia, occuring in =5% of subjects included nasopharyngitis, upper respiratory tract infection, nausea, diarrhea and back pain.1
FIASP® (insulin aspart injection)
for subcutaneous or intravenous use
Do not share your FIASP with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.
What is FIASP?
Who should not take FIASP?
Do not take FIASP if you:
Before taking FIASP, tell your healthcare provider about all your medical conditions including, if you:
Before you start taking FIASP, talk to your healthcare provider about low blood sugar and how to manage it.
How should I take FIASP?
What should I avoid while taking FIASP?
While taking FIASP do not:
What are the possible side effects of FIASP?
FIASP may cause serious side effects that can lead to death, including:
Your insulin dose may need to change because of:
Treatment with TZDs and FIASP may need to be adjusted or stopped by your healthcare provider if you have new or worse heart failure.
Common side effects of FIASP may include:
These are not all the possible side effects of FIASP. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of FIASP.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your pharmacist or healthcare provider for information about FIASP that is written for health professionals. Do not use FIASP for a condition for which it was not prescribed. Do not give FIASP to other people, even if they have the same symptoms that you have. It may harm them.
What are the ingredients in FIASP?
Active Ingredient: insulin aspart
Inactive Ingredients: glycerol, phenol, metacresol, zinc, disodium phosphate dihydrate, arginine hydrochloride, niacinamide and water for injections
Novo Nordisk A/S
DK-2880 Bagsvaerd, Denmark
For more information, go to www.novonordisk-us.com or call 1-800-727-6500.
This Patient Information has been approved by the U.S. Food and Drug Administration
Approved: September 2017
Please see Prescribing Information at http://www.novo-pi.com/fiasp.pdf.
In the United States, more than 30 million people are affected by diabetes. Type 2 diabetes accounts for 90 to 95 percent of all diabetes cases.3 Diabetes is emerging as one of the most serious health problems of our time; the number of Americans with diabetes has quadrupled over the past 30 years.4
About Novo Nordisk
Novo Nordisk is a global healthcare 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. With U.S. headquarters in Plainsboro, N.J., Novo Nordisk Inc. has nearly 5,000 employees in the United States. For more information, visit novonordisk.us or follow us on Twitter: @novonordiskus.
Fiasp®, NovoLog® and FlexTouch® are registered trademarks of Novo Nordisk A/S.
Novo Nordisk is a registered trademark of Novo Nordisk A/S.
© 2017 Novo Nordisk All rights reserved. USA17INS02464 September 2017
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