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:5/20/2016)... According to the 2016 home healthcare ... for affordable healthcare solutions as since the early 2000s, the ... countries like the US, the healthcare cost rose faster than ... price index inflation rate stood at an average of 2.04% ... 3.62% during the same time period. This can be attributed ...
(Date:5/19/2016)... Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) announced today that it is ... a chance to meet iconic entertainer Mario Kreutzberger ... past two years has been the face of the company,s ... with type 2 diabetes, which Don Francisco is ... and tips for long-term healthy lifestyle choices. ...
(Date:5/19/2016)... , The data will be presented in ...   The conclusions of the study point to ... with 90% of the m presenting duration ... percent of the patients had clinical benefit.   ... I study of plitidepsin in combination with bortezomib and dexamethasone in patients with ...
Breaking Medicine Technology:
(Date:5/24/2016)... (PRWEB) , ... May 24, 2016 , ... ... trip to the Dominican Republic on September 21, 2016. Dr. Gerard, who holds ... serves with ChiroMission, a not-for-profit organization promoting health and wellness in Third World ...
(Date:5/24/2016)... Milwaukee, WI (PRWEB) , ... May 24, 2016 ... ... Facility In Milwaukee , Out patient Services To Begin In June , Aloria ... is pleased to announce the opening of Aloria Milwaukee, its first treatment facility ...
(Date:5/24/2016)... (PRWEB) , ... May 24, 2016 , ... "ProText Layouts ... said Christina Austin - CEO of Pixel Film Studios. , ProText Layouts Vol. 3 ... Final Cut Pro X . With ProText Layouts, video editors can create an ...
(Date:5/24/2016)... (PRWEB) , ... May 24, 2016 , ... The old ... causing the problem. A common injury that’s often misunderstood, whiplash should be swiftly diagnosed ... a Harvard-trained, orthopedic spine surgeon at Atlantic Spine Center . , So ...
(Date:5/24/2016)... ... May 24, 2016 , ... Since 1946, the doctors ... care. From the moment a patient arrives at the office, the staff will ... with each and every patient to create a complete dental treatment plan that is ...
Breaking Medicine News(10 mins):