Navigation Links
Novo Nordisk Submits First Recombinant Treatment for Factor XIII Deficiency for U.S. Regulatory Approval
Date:2/23/2011

PRINCETON, N.J., Feb. 23, 2011 /PRNewswire/ -- Novo Nordisk announced today that a Biologic License Application (BLA) has been submitted to the U.S. Food and Drug Administration (FDA) requesting the approval of a recombinant factor XIII compound (rFXIII) for the vast majority of patients with congenital factor XIII (FXIII) deficiency, an inherited bleeding disorder(1). The company anticipates filing its marketing authorization application to the European Medicines Agency in Q2 2011.

Currently, FXIII deficient patients are treated with products derived from human blood plasma(2), which carry an inherent risk of contamination. Treatments created using recombinant technology are genetically engineered and not sourced from human blood or plasma. The use of this technology in the development of treatments helps to reduce the potential risk of transmitting blood-borne illnesses.

Patients with congenital FXIII deficiency have a lifelong susceptibility towards bleeding problems, including spontaneous intracranial hemorrhage. Caused by a lack of the protein clotting factor XIII, FXIII congenital deficiency has a prevalence of one case per two million people(2). With an estimated 600 diagnosed patients worldwide, FXIII deficiency is considered one of the rarest bleeding disorders(3).

"Novo Nordisk is committed to serving the bleeding disorder community, and this submission marks a major milestone in the expansion of our product offerings to this patient group," said Eddie Williams, Vice President of Biopharmaceuticals at Novo Nordisk. "The development of a treatment that does not depend on blood products is an important step for the hundreds of patients affected worldwide by congenital FXIII deficiency."

Positive results from a phase 3 trial examining the efficacy and safety of rFXIII for the prevention of bleeds associated with congenital FXIII deficiency showed that when compared to a historic control group of individuals who did not receive routine FXIII infusions, preventive treatment with monthly recombinant FXIII injections significantly decreased the number of bleeding episodes requiring treatment. These data were presented at the American Society of Hematology (ASH) meeting in December 2010, and marked the first completed phase 3 study conducted to study the use of a recombinant FXIII treatment to prevent bleeding episodes in congenital FXIII deficiency patients.

In the trial, 41 patients were observed over one year, with rFXIII administered as a preventive, once-monthly replacement therapy for FXIII congenital deficiency. Over the course of the treatment period, a total of five bleeding episodes, all associated with trauma and requiring additional FXIII treatment, were observed in four patients. Additionally, no thromboembolic events or fatal adverse events were reported.

About Novo Nordisk Novo Nordisk is a global healthcare company with more than 87 years of innovation and leadership in diabetes care. The company also has leading positions within hemophilia care, growth hormone therapy and hormone therapy for women. Novo Nordisk's business is driven by the Triple Bottom Line: a commitment to social responsibility to employees and customers, environmental soundness and economic success. Headquartered in Denmark, Novo Nordisk employs more than 30,000 employees in 81 countries, and markets its products in 179 countries. Novo Nordisk's B shares are listed on the stock exchange in Copenhagen. Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk-us.com. Media:

Investors:Outside North America:

Outside North America:Rachel Curtis Gravesen

Klaus Bulow DavidsenTel: (+45) 4442 7603

Tel: (+45) 4442 3176rcgv@novonordisk.com

klda@novonordisk.comIn North America:

Kasper Roseeuw Poulsen Sarah Spielvogel

Tel: (+45) 4442 4471Tel: (+1) 609 240 5333

krop@novonordisk.comsspv@novonordisk.comJannick LindegaardTel: (+45) 4442 4765jlis@novonordisk.comIn North America:Hans RommerTel: (+1) 609 919 7937hrmm@novonordisk.com(1)  Bolton-Maggs PH, Perry DJ, Chalmers EA, et al. The rare coagulation disorders--review with guidelines for management from the United Kingdom Haemophilia Centre Doctors' Organisation. Haemophilia 2004; 10: 593–628.

(2)  Karimi M et al.  Factor XIII deficiency. Semin Thromb Haemost 2009;35(4): 426-38.

(3)  National Hemophilia Foundation.  Factor XIII.  http://www.hemophilia.org/NHFWeb/MainPgs/MainNHF.aspx?menuid=190&contentid=58&rptname=bleeding.  Accessed February 8, 2011.
'/>"/>

SOURCE Novo Nordisk
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Novo Nordisk Creates First Mobile Application to Help Doctors Diagnose Bleeding Disorders
2. Novo Nordisk Intends to Appeal Adverse Ruling in Prandin® (repaglinide) Patent Case
3. Reportlinker Adds Novo Nordisk A/S: PharmaVitae Profile
4. Novo Nordisk A/S and Emisphere Technologies, Inc. Announce License Agreement to Develop Oral Formulation of Insulin for Diabetes
5. Novo Nordisk and Chip Ganassi Racing Team Up for 2011 IZOD IndyCar Series
6. Novo Nordisk and Entertainment Industries Council Work Together to Improve Public Education and Awareness about Diabetes Epidemic
7. Novo Nordisk to Invest $73m in Expansion of U.S. Manufacturing Facility
8. Novo Nordisk Inc. Announces Exclusive Agreement With Upsher-Smith Laboratories, Inc. to Market Vagifem® 10 mcg
9. Novo Nordisk Addresses Innovation in Diabetes Care in Second Issue of Industry Resource for Information on Diabetes and Chronic Disease
10. Novo Nordisk Announces Resources to Help Support Kids with Diabetes Attending Summer Camp
11. Novo Nordisk Awards More Than $300,000 in Grants to Support Education and Community Health Programs
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/30/2021)... ... March 29, 2021 , ... The University of Texas Health Science Center ... San Antonio Multispecialty and Research Hospital, a destination center for research and treatment of ... In a nod to the COVID-19 pandemic, the ceremony was held virtually. , William ...
(Date:3/30/2021)... ... March 29, 2021 , ... Iora Health ... primary care, has partnered with Devoted Health , one of the fastest-growing ... across Maricopa County and provides seniors with the highest-quality care and experience possible, ...
(Date:3/30/2021)... CITY (PRWEB) , ... March 29, 2021 , ... ... has joined the Vaccine Credential Initiative (VCI), a group bringing together leading health ... record of vaccination status, based on open, interoperable standards. By joining the VCI ...
Breaking Medicine Technology:
(Date:3/30/2021)... , ... March 29, 2021 , ... ... the 21st Century , A Virtual Workshop Presented by WCG FDAnews and Cerulean ... 4:30 pm EDT, https://wcg.swoogo.com/modern-sop-and-quality-systems , Are one’s SOPs written for the ...
(Date:3/30/2021)... ... March 29, 2021 , ... According to data released ... reproductive age (13-44) in need of publicly funded contraception live in counties impacted by ... Colorado’s 64 counties have lost some of their Title X resources. , The ...
(Date:3/30/2021)... ... March 29, 2021 , ... Health Literacy Innovations (HLI), a ... confusion due to low health literacy today announces a new partnership with the ... work with ACAP’s member Safety Net Health Plans, those that provide comprehensive health ...
(Date:3/30/2021)... ... ... Dr. Colin Campbell is proud to announce the 1 year anniversary in their new state ... internal medicine and is a primary care specialist who has been practicing for 23 years. ... keep South Jersey healthy one patient at a time. , “Over the past year, Dr. ...
(Date:3/30/2021)... ... March 30, 2021 , ... The COVID-19 ... and survivors; their families; and their caregivers. Crossroads4Hope is addressing the needs of ... emotional support system, MyGo2Support, which meets needs of people impacted by cancer, no ...
Breaking Medicine News(10 mins):