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 Denmar
'/>"/>

SOURCE Novo Nordisk
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2

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:1/23/2015)... Rose, baseball,s all-time hits leader, is the new spokesperson for ... Pharma has announced. "Pete,s a Hall of Famer ... on board with Myoflex," said Ducere Pharma Chief Executive Officer ... is known across all generations. The passion and intensity that ...
(Date:1/23/2015)... 2015  Now available for sale, The Armor1 Ankle Roll ... ankle sprains by cushioning the ankle from an inversion ... the outside of any shoe type and allows the ... offering protection against sprains. With customers in physical therapy, ...
(Date:1/23/2015)... SETAUKET, N.Y. , Jan. 23, 2015  Lixte Biotechnology Holdings, ... where its Phase I trial of Lixte,s lead compound, LB‑100, ... institutions. John S. Kovach , M.D., the ... was planned to be completed at a single site. Accrual ...
Breaking Medicine Technology:Pete Rose bets on Myoflex to relieve aches and pains 2The Armor1 Ankle Roll Guard is the New Breakthrough Solution for Ankle Sprain Prevention! 2Lixte Biotechnology Holdings Announces Expansion Of Clinical Sites For Its Phase I Trial Of Its Lead Anti-Cancer Compound, LB-100 2Lixte Biotechnology Holdings Announces Expansion Of Clinical Sites For Its Phase I Trial Of Its Lead Anti-Cancer Compound, LB-100 3
... WALTHAM, Mass. , March 22 Interleukin Genetics, Inc. (NYSE ... the NYSE Amex LLC (the "Exchange") has granted the Company an extension ... will remain listed up to June 23, 2010 , subject to ... towards the Company,s plan to regain compliance. , ...
... and Manufacturers of America (PhRMA) issued the following statement today on passage of comprehensive health care reform and accompanying reconciliation legislation in the U.S. House of Representatives: , ... , ... ... ...
Cached Medicine Technology:NYSE Amex Provides Interleukin Genetics, Inc. Extension To Meet Continued Listing Standards 2NYSE Amex Provides Interleukin Genetics, Inc. Extension To Meet Continued Listing Standards 3PhRMA Statement on Health Care Reform 2PhRMA Statement on Health Care Reform 3PhRMA Statement on Health Care Reform 4PhRMA Statement on Health Care Reform 5
(Date:1/22/2015)... Blue Cross and Blue Shield of Minnesota (Blue Cross) wants ... “Live Fearless.” , The “Faces of Fearless” campaign ... how they or someone they know has faced a challenge, ... moment. By telling these types of stories through livefearlessmn.com, participants ...
(Date:1/22/2015)... January 22, 2015 Thousand of GranuFlo ... Care recalled its GranuFlo and NaturaLyte dialysis concentrates continue ... in U.S. District Court, District of Massachusetts, Bernstein Liebhard ... the Court has remanded a case filed by the ...
(Date:1/22/2015)... January 22, 2015 A study ... Medicine flagship journal Medicine & Science in Sports ... exercise may help reduce gastrointestinal (GI) problems associated ... , Participants in the double-blind, placebo-controlled study took ...
(Date:1/22/2015)... 22, 2015 Payday lending practices in ... and cause financial distress to the states that permit ... Howard University’s Center on Race and Wealth. , While ... activity, payday loans at the same time substantially depress ...
(Date:1/22/2015)... (PRWEB) January 22, 2015 Lower-Auto-Insurance.com has released a ... kit in a car for reducing the costs of an ... will also be able to get lower prices for their vehicle ... an important role in determining policy costs. Because of this, ...
Breaking Medicine News(10 mins):Health News:Blue Cross and Blue Shield of Minnesota to Showcase “Faces of Fearless” 2Health News:Court Overseeing Federal GranuFlo Lawsuits Remands Louisiana Claim Back to State Court, Bernstein Liebhard LLP Reports 2Health News:Court Overseeing Federal GranuFlo Lawsuits Remands Louisiana Claim Back to State Court, Bernstein Liebhard LLP Reports 3Health News:Court Overseeing Federal GranuFlo Lawsuits Remands Louisiana Claim Back to State Court, Bernstein Liebhard LLP Reports 4Health News:Study Shows Kyowa Hakko’s L-Citrulline May Help Reduce Gastrointestinal Injury During Strenuous Exercise 2Health News:Study Shows Kyowa Hakko’s L-Citrulline May Help Reduce Gastrointestinal Injury During Strenuous Exercise 3Health News:Howard University Spotlights the Economic Impact of Payday Lending in Southern States 2Health News:Driving Safe And Other Factors That Make Auto Insurance Affordable! 2
... MEDmarketplace.com announced today that it has been awarded a ... contracting entity for the Sisters of Mercy Hospital System ... marketplace for selling surplus medical equipment and supplies. ... the agreement, Mercy,s 18 acute care hospitals, two heart ...
... CHICAGO, Dec. 4 The Neurologic & Orthopedic Hospital of,Chicago ... Chicago,Red Stars, a charter member of Women,s Professional Soccer, a ... world. The NOHC will,also be an official partner of ... , Heading the medical ...
... format for its “OneMedForum 2009” finance conference, ... San Francisco at the Sir Francis Drake ... disrupters” affecting each of the following medtech ... and Neurostimulation; Cardiology; Urology and Sexual Health; ...
... Kenneth K. Westbrook, a leading executive in Southern ... Chief Executive Officer of Integrated Healthcare Holdings, Inc., effective ... hospitals in Orange County, California: Western Medical Center -- ... Center and Coastal Communities Hospital. , ...
... blood pressure does not improve a common form of ... international study. , The study, which included researchers ... leadership positions, appears in this week,s issue of the ... , The findings are disappointing to researchers, who continue ...
... programs to help consumers make informed health care decisions , ... While data indicates that area doctors are doing a ... health of their employees, none of this matters if consumers ... to research released today by the Dallas-Fort Worth Business Group ...
Cached Medicine News:Health News:MEDmarketplace.com Signs Contract with Resource Optimization & Innovation (ROi) to Sell Surplus Hospital Equipment 2Health News:MEDmarketplace.com Signs Contract with Resource Optimization & Innovation (ROi) to Sell Surplus Hospital Equipment 3Health News:Neurological & Orthopedic Named Official Hospital of Chicago Red Stars Women's Pro Soccer Team 2Health News: OneMedPlace announces panels for "OneMedForum 2009: Disrupters and Drivers in Eight Areas of Medical Technology" -- CEOs and investors to meet in unique format of focused sessions 2Health News:Integrated Healthcare Holdings, Inc. Announces New Chief Executive Officer 2Health News:Study finds treatment fails to improve common form of heart failure 2Health News:Study finds treatment fails to improve common form of heart failure 3Health News:Partnership for Peak Healthcare Performance Research Shows Consumers' Lack Involvement in Managing Their Health 2Health News:Partnership for Peak Healthcare Performance Research Shows Consumers' Lack Involvement in Managing Their Health 3Health News:Partnership for Peak Healthcare Performance Research Shows Consumers' Lack Involvement in Managing Their Health 4
The anti-MAG autoantibodies EIA employs the quantitative enzymatically amplified sandwich-type immunoassay technique. HIGHLY PURIFIED MAG FROM HUMAN BRAIN has been precoated onto a microtiter plate....
... new Enzyme Immuno Assay (EIA) analyzer offering ... a dedicated EVO platform for reliable EIA ... and incubation units operated by the new ... available in three sizes - 100, 150, ...
... trial for 14 years -- and works! ... employs cutting-edge, patent-pending technology to attain the ... unsurpassed accuracy. The technique traces the amount ... blood to determine gender. Here's how it ...
Custom Pediatric Nebulizer Assembly W/Tubing...
Medicine Products: