FDA approves Fiasp® for treatment of children with diabetes
PLAINSBORO, N.J., Jan. 6, 2020 – Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) has approved Fiasp® (insulin aspart injection) 100 u/mL for use as a new mealtime insulin option for children with diabetes.1 Fiasp® is the first and only fast-acting mealtime insulin injection that does not have a pre-meal dosing recommendation. Fiasp® is now available for use in children and adults in three different dosing options: multiple daily injections (MDI), continuous subcutaneous insulin infusion pumps and intravenous infusion under supervision by a healthcare professional.
Diabetes is one of the most common chronic conditions diagnosed in childhood, with nearly 18,000 new cases of type 1 diabetes each year.2,3 Managing diabetes can be challenging for parents and caregivers given it is hard to know exactly how much or how quickly their children will eat, making mealtime insulin dosing difficult.3,4,5 Conventional rapid-acting insulins must be administered ahead of meals, which requires some guesswork to dose properly, and children living with diabetes may not achieve adequate blood sugar control.3,4,5,6
“As a parent of a son living with type 1 diabetes, I know first-hand how tough it can be to address the inevitable blood sugar spikes around mealtimes,” said Todd Hobbs, vice president and U.S. chief medical officer of Novo Nordisk. “Children can be unpredictable and having the option of a fast-acting insulin that doesn’t require pre-meal dosing like Fiasp® is a welcome development for the diabetes community.”
The approval is based on the FDA's review of data from the onset 7 clinical trial, which confirmed the efficacy and safety of Fiasp® in children. 7
For information on cost and savings offers, including co-pay and patient assistance programs, visit myfiaspcost.com.
Novo Nordisk Receives FDA Approval of Tresiba® for Use in Children
Novo Nordisk Receives FDA Approval of Tresiba® (insulin degludec injection 100 U/mL, 200 U/mL) for Use in Children and Adolescents With Diabetes
Tresiba® is the only long-acting insulin approved for use in people with type 1 and type 2 diabetes as young as age one
PLAINSBORO, N.J., Dec. 19, 2016 /PRNewswire/ -- Novo Nordisk, a world leader in diabetes care, today announced that the U.S. Food and Drug Administration (FDA) approved an expanded indication for Tresiba® (insulin degludec injection 100 U/mL, 200 U/mL), a once-daily, long-acting basal insulin, to be used in children and adolescents with diabetes. Tresiba®, first approved by the FDA in September 2015, is now indicated to improve glycemic control in patients with type 1 and type 2 diabetes from the age of one through adulthood,1making it the only basal insulin approved for both type 1 and type 2 diabetes in patients as young as 1 year old. Tresiba® is a long-acting insulin that is released over time, has a 25 hour half-life and has a consistently flat and stable profile at steady state.1
"We are seeing a rise in the number of children and adolescents with diabetes in the U.S., especially those with type 2, and are proud to support these patients by offering new and effective treatment options," said Todd Hobbs, M.D., U.S. chief medical officer, Novo Nordisk.2 "It can be challenging for children with type 1 diabetes and their parents to manage blood sugar levels and keep up with multiple injections throughout an already busy day. With this approval, they now have another option of a long-acting insulin that is dosed once daily."
Novo Nordisk submitted the supplemental New Drug Application (sNDA) based on the results of the BEGIN™ Young 1 trial, a multi-national, 26-week, phase 3b, randomized, controlled, open-label, parallel-group, treat-to-target non-inferiority trial with a 26-week extension. BEGIN™ Young 1 compared the efficacy and safety of Tresiba® administered once-daily compared with Levemir® (insulin detemir [rDNA origin] injection) administered once-daily or twice daily, both in combination with insulin aspart, a mealtime insulin, in children and adolescents with type 1 diabetes aged 1 to 17. The results showed that Tresiba® in combination with insulin aspart effectively improved glycemic control. The most common adverse events were infection, hypoglycemia and hyperglycemia.3 The use of Tresiba® in patients one year of age and older with type 2 diabetes mellitus is also supported by evidence from adequate and well-controlled studies in adults with type 2 diabetes.1
Once-daily Tresiba® (insulin degludec injection 100 U/mL, 200 U/mL) is available in Novo Nordisk's latest insulin delivery device – FlexTouch® – as a 100 units/mL or 200 units/mL pen. Tresiba® U-100 FlexTouch® can deliver up to 80 units of insulin in a single injection. Tresiba® U-200 FlexTouch® can dose up to 160 units in a single injection. FlexTouch® is also the only prefilled insulin pen with no push-button extension.1
Eligible patients with commercial insurance can use the Tresiba® Instant Savings Card to reduce co-pays to as low as $15 a month for up to 24 months. Eligibility and other restrictions apply. For complete terms and conditions and any questions regarding eligibility, visit https://www.tresiba.com/instant-savings-card/eligibility.html or call 1-855-834-3466.
Contest: Guess Arden's New Puppy's Name
Arden has been asking for a puppy forever and today she got her wish when her Christmas present arrived at the airport.
Arden spent the past weeks thinking of names for her new best friend, she took suggestions from family and friends, looked through baby name books, but in the end she decided on a name all on her own - and it's a diabetes centric name.
So the first person who can guess what Arden named her new puppy wins three pairs of blue circle shoe laces. The contest runs until someone gets the name correct. If more than one person guesses correctly I'll give three pairs to the first correct guess and one pair to each of the others but the contest will be shutdown twelve hours after the initial correct guess is made.
Puppy is three months old. He's a mix of French Bulldog and Boston Terrier. They call him a Faux French, he's such a cutie!
Okay, I'm exhausted from driving to the airport at four in the morning (he missed a connecting flight) so I'm going to take it easy while you try to figure out his name. Remember, it's diabetes related... good luck!
Only two rules: All guesses must be made in the comments of this post. Open to US and Canadian residents only for shipping cost reasons.
Arden named her new puppy Basal...
It's a Diabetes Shoelaces Extravaganza on Arden's Day
Watch the video and then I'll explain...
So like I said in the video the cost of shipping is falling to my family, Usually we'd eat the cost but it's going to be a bit much so when I figure out how to do this... the one provision will be that anyone who wants a pair will have to pay the shipping costs - I'll know how much that will be next week.
Here's the next part. On Monday I'll be speaking with some people from Novo and I'm going to try to get them to see how popular the Novo #LaceUp4Diabetes laces are in the diabetes community. My hope is to talk them into making them available on a much larger scale in the future. With that in mind, it would be a huge help if you took a moment to let Novo know, here in the comments, how much you want the laces!
A huge thank you to Novo Nordisk, my wife Kelly and the great people she works with for giving up their laces for the DOC!
Giveaway! Blue Circle Shoelaces and Signed Books
What do you say we honor Diabetes Awareness Month by giving away some fresh diabetes swag?!
the giveaway items
Five pairs of those swanky blue circle shoelaces that you see all of the cool diabetes advocates wearing – courtesy of Novo Nordisk.
One signed copy of my book, Life Is Short, Laundry Is Eternal: Confessions of a Stay-At-Home Dad
One signed copy of Moira McCarthy's book, Raising Teens with Diabetes
how to enter
Complete as many entry options as you want using the Rafflecopter app below, each option gives you a different number of chances to win and some options can be performed daily.
choosing winners and other stuff you should know
Giveaway is only open to folks with US and Canadian addresses (I'm paying for shipping). Contest ends 11/30/2014 at midnight EST. Winners will be drawn at random by the Rafflecopter app. One prize per household.
Happy Diabetes Awareness Month!