Navigation Links
FDA Approves Product to Prevent Bleeding in People With Rare Genetic Defect
Date:2/17/2011

SILVER SPRING, Md., Feb. 17, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Corifact, the first product intended to prevent bleeding in people with the rare genetic defect congenital Factor XIII deficiency.

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

Patients with congenital Factor XIII deficiency don't make enough Factor XIII, a substance that circulates in the blood and is important for normal clotting. Without treatment, people with the condition are at risk for life-threatening bleeding.

Congenital Factor XIII deficiency is rare and affects 1 out of every 3 million to 5 million people in the United States. The deficiency may lead to soft tissue bruising, mucosal bleeding and fatal intracranial bleeding. Newborns with Factor XIII deficiency may have umbilical cord bleeding.

"This product helps fill an important need," said Karen Midthun, M.D., director of the FDA's Center for Biologics Evaluation and Research.

Corifact received orphan-drug designation by the FDA because it is intended for use in a rare disease or condition. It was approved for marketing under the FDA's accelerated approval regulations that require an on-going study to demonstrate that patients actually receive the clinical benefit predicted by the data obtained so far.

The FDA approved Corifact based on results of a clinical study of 14 people, including children, with congenital Factor XIII deficiency. The most common side effects observed were hypersensitivity reactions (allergy, rash, pruritus, and erythema), chills, fever, arthralgia, headache, elevated thrombin-antithrombin levels, and an increase in liver (hepatic) enzymes.

Corifact is made from the pooled plasma of healthy donors. People receiving Corifact may develop antibodies against Factor XIII that may make the product ineffective. It potentially can cause adverse events from abnormal clotting if doses higher than the labeled dose are given to patients.

Corifact is manufactured by CSL Behring of Marburg, Germany.

For more information:

CBER product approval page:

http://www.fda.gov/BiologicsBloodVaccines/ucm133705.htm

Orphan Products: Hope for People With Rare Diseases

http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm143563.htm

Media Inquiries: Shelly Burgess, 301-796-4651, shelly.burgess@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA


'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. FDA Approves First 3-D Mammography Imaging System
2. FDA Approves 1st Pacemaker Designed to Work Safely During Some MRI Exams
3. FDA Approves Hologics Makena™ (Formerly Referred to as Gestiva™) Pharmaceutical
4. FDA Approves Drug to Reduce Risk of Preterm Birth in At-Risk Pregnant Women
5. FDA Approves Makena™, the First and Only Treatment to Reduce the Risk of Preterm Birth in Women With a Singleton Pregnancy Who Have a History of Singleton Spontaneous Preterm Birth
6. FDA Approves Viibryd to Treat Major Depressive Disorder
7. FDA Approves Head Lice Treatment for Children and Adults
8. FDA Approves Opioid Analgesic to Help Cancer Patients Manage Pain
9. VIDEO from Endo Pharmaceuticals Available on thenewsmarket.com: FDA Approves New Treatment for Low Testosterone
10. FDA Approves New Dosage Strength for INTELENCE®
11. U.S. FDA Approves Second Bayer Oral Contraceptive That Also Raises Folate Levels
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/3/2017)... , May 3, 2017 A Catheterization ... hospital or healthcare facility. Commonly referred to as ... equipped with diagnostic imaging technology to give physicians ... heart. In these spaces, a team of physicians ... angioplasty, percutaneous coronary intervention, congenital heart defect closure, ...
(Date:5/3/2017)... , May 3, 2017  Getinge, a ... contribute to quality enhancement and cost efficiency within ... a study of contemporary practice demonstrating that intra-aortic ... therapy for critically ill patients. The single-center, retrospective, ... newer large volume MEGA ® 50cc intra-aortic ...
(Date:5/2/2017)... NEW YORK and ... the leading distributor of market intelligence, MarketResearch.com is pleased ... Tech Reimbursement Consulting AB that allows for the ... AB,s proprietary market analyses through the MarketResearch.com website. ... world easy access to complete product descriptions and tables ...
Breaking Medicine Technology:
(Date:5/26/2017)... (PRWEB) , ... May 26, 2017 , ... ... be this year’s recipient of proceeds from its 14th Annual Clays for Kids ... E. County Road 30, Bennett, Colorado. , As part of BluSky’s partnership ...
(Date:5/26/2017)... ... 26, 2017 , ... “Cactus Jack: Against All Odds”: the story of Coach ... Jack: Against All Odds” is the creation of published author, Walter Hubbard, a retired ... Jack Carlisle’s third child Jane. Walter. Walter and Jane have three adult children ...
(Date:5/24/2017)... , ... May 24, 2017 , ... ... Medical Center CEO Mary Ellen, hospital employees, and town officials to celebrate the ... The facility was developed by Rendina as part of its ongoing relationship with ...
(Date:5/24/2017)... ... May 24, 2017 , ... Dr. Alan I. Benvenisty, ... in New York City. He is known for his distinguished expertise and experience in ... Dr. Benvenisty holds sub-specialty training in treating renovascular disease and aortic aneurysm . ...
(Date:5/24/2017)... ... May 24, 2017 , ... ... and interpretation, has received U.S. Food and Drug Administration (FDA) 510(k) clearance ... scalable and secure cloud platform for medical image management. At the core is ...
Breaking Medicine News(10 mins):