Navigation Links
Insulin degludec and insulin degludec/insulin aspart receive positive vote for approval from FDA Advisory Committee
Date:11/8/2012

WASHINGTON, Nov. 8, 2012 /PRNewswire/ -- Novo Nordisk today announced that the Endocrinologic and Metabolic Drugs Advisory Committee of the United States Food and Drug Administration (FDA) has completed its meeting regarding the New Drug Applications (NDA) for insulin degludec and insulin degludec/insulin aspart.

(Logo:  http://photos.prnewswire.com/prnh/20110414/NY80976LOGO )

At the meeting, the Advisory Committee was asked to discuss the data contained in the NDAs and subsequent submissions regarding the benefits and risks of the products, including a lower rate of hypoglycemia and the potential cardiovascular risk profiles of the two products.

The FDA asked the panel members to vote on whether a cardiovascular outcomes trial should be conducted and whether sufficient safety and efficacy data had been provided to support marketing of insulin degludec and insulin degludec/insulin aspart.

The committee unanimously recommended that a cardiovascular outcomes trial should be conducted and voted 8-4 in favor of approving the products with a post-approval outcomes trial commitment.

"The positive vote from the Advisory Committee marks an important step toward making insulin degludec and insulin degludec/insulin aspart available to adult patients with diabetes in the U.S. We look forward to completing the regulatory process with the agency, including the design of the post-approval cardiovascular outcomes trial," said Alan Moses, global chief medical officer of Novo Nordisk.

The FDA has not informed Novo Nordisk of when it expects to complete its review of the NDAs.

Conference call

On November 9 at 8:30 am CET (Central European Time), corresponding to 2:30 am EST, a conference call for investors will be held. Investors will be able to listen in via a link on the investor section of novonordisk.com.

Headquartered in Denmark, Novo Nordisk is a global healthcare company with 89 years of innovation and leadership in diabetes care. The company also has leading positions within hemophilia care, growth hormone therapy, and hormone replacement therapy. For more information, visit novonordisk-us.com or follow our news in the US on Twitter: @NovoNordiskUS


'/>"/>
SOURCE Novo Nordisk
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Biodels Intellectual Property Position Strengthened for Ultra-Rapid-Acting Insulin Programs by Notice of Intent to Grant from European Patent Office
2. Glytec Adds Pediatric Insulin Dosing to its IV and SubQ FDA Clearances
3. Valeritas Inc. Selects dLifes New Diabetes Patient Engagement Solution For Valeritas V-go Disposable Insulin Delivery Device
4. Halozymes Ultrafast Insulin Formulations Improved Postprandial Glycemic Control in Patients Living with Type 1 Diabetes: Phase 2 Study Results Presented at ADA 2012
5. Lilly and Boehringer Ingelheim Present Data at the 72nd American Diabetes Association Scientific Sessions® from Phase II Studies Comparing Investigational Novel Basal Insulin to Insulin Glargine
6. FDA clears Accu-Chek Combo system - Roches new interactive insulin pump system for people with diabetes
7. Biodel Awarded NIH Grant to Develop Concentrated Ultra-Rapid-Acting Insulin Formulations for Use in Artificial Pancreas
8. In Pilot Study, a Peptide Controls Blood Sugar in People with Congenital Hyperinsulinism
9. montméd, Inc. to Market FRiO Insulin Wallets in 20 countries of Middle East and North Africa
10. Biodel Announces Phase 2 Clinical Trial Initiation Of Ultra-Rapid-Acting Insulin Candidate BIOD-123
11. Global Insulin Market Expected to Reach USD 32,346.7 Million in 2018, with China Alone Accounting for 10.2%: Transparency Market Research
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/25/2016)... CORAL SPRINGS, Florida , May 25, 2016 /PRNewswire/ ... Marijuana Business Conference & Expo earlier this month, the ... undeniable. As revenues continue to climb into the billions, ... to the newly released 4th Edition State of Legal ... New Frontier, a cannabis-focused data-analysis firm, much of the ...
(Date:5/25/2016)... 25, 2016 MedDay, a biotechnology company ... an oral presentation entitled "High doses of biotin in progressive ... be given by Professor Ayman Tourbah , Principal Investigator ... the European Academy of Neurology (EAN) in Copenhagen, ... 3" will take place on Sunday, 29 May 2016 from ...
(Date:5/24/2016)... May 24, 2016 Niederländische ... gebracht, die es Ärzten erlaubt, ihre Expertise weltweit ... MDLinking kombiniert Live Streaming mit einer Instant-Messaging-Funktion und ... kommunizieren. Mediziner in Europa, Afrika, Asien und den ... für die Plattform registriert. Information und ...
Breaking Medicine Technology:
(Date:5/26/2016)... ... May 26, 2016 , ... Development Team of Pixel Film Studios Announced ... "This new layered style transition tool will keep a consistent flow to your project ... Film Studios. , TranSweep is an all new layered style transition tool for ...
(Date:5/26/2016)... ... May 26, 2016 , ... Dalton Pharma Services, ... has successfully completed another Health Canada inspection and has received a compliant rating ... resulted from a Good Manufacturing Practices (GMP) inspection conducted at Dalton’s facility during ...
(Date:5/26/2016)... ... 26, 2016 , ... Women’s athletic apparel company GRACEDBYGRIT is ... shop for three consecutive weekends. The pop-up shop is a great way to ... community full of women who appreciate the most premium goods and vibrant events. ...
(Date:5/26/2016)... ... 26, 2016 , ... Bunion Bootie is a great option for ... save. For a limited time only (offer expires May 31, 2016) customers can save ... by using the promo code "Memorial" at checkout. The more Bunion Booties purchased, the ...
(Date:5/25/2016)... ... May 25, 2016 , ... ... Association/American Stroke Association's Get With The Guidelines®-Stroke Gold Plus Achievement Award with ... second for Memorial Healthcare System, recognizes its commitment to emergency stroke care ...
Breaking Medicine News(10 mins):