Navigation Links
FDA Approves Product to Prevent Bleeding in People With Rare Genetic Defect

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.


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:

Orphan Products: Hope for People With Rare Diseases

Media Inquiries: Shelly Burgess, 301-796-4651,

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 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:
(Date:12/1/2015)... ) has ... Systems/Personal Emergency Response System (PERS) Market by Type, ... report to their offering. --> ... "Medical Alert Systems/Personal Emergency Response System (PERS) ... - Global Forecas" report to their offering. ...
(Date:12/1/2015)... -- --> --> ... (NKI-AVL), among the world,s largest and most prestigious ... Icon™, the company,s latest generation stereotactic radiosurgery system ... --> With the option to use ... Knife Icon offers greatly enhanced flexibility in how ...
(Date:12/1/2015)... Colo. , Dec. 1, 2015 Ampio ... New York Stock Exchange has established January 5, 2016 as ... its stockholders of the shares of Common Stock of ... (1) share of Aytu common stock for every five ... the record date, December 1, 2015. The distribution date will ...
Breaking Medicine Technology:
(Date:12/1/2015)... ... 2015 , ... For many X-rays taken at hospitals, doctors’ ... by the radiologist. The marking utensils are so small, however, they are difficult ... way to alleviate this problem. , He developed the patent-pending MARK N SHOW ...
(Date:12/1/2015)... CA (PRWEB) , ... December 01, 2015 , ... ... Health Center of Excellence (BHCOE) today announced that the organization has awarded Education ... San Francisco, with a Distinguished Award. The award celebrates exceptional special needs providers ...
(Date:12/1/2015)... Burlington, MA (PRWEB) , ... December 01, 2015 , ... ... the release of Clarity, the latest addition to the devices for sale in the ... technologies, 755 nm Alexandrite and long-pulsed 1064 nm Nd:YAG lasers, into a single platform ...
(Date:12/1/2015)... ... , ... XTC Semifinals 2016 - CES, Las Vegas, Nevada - ... CES 2016, the world’s largest Consumer Electronic Show, where they will present to a ... of Pacific Investments Veronica Serra, and venture capitalist Tim Draper among many other top ...
(Date:12/1/2015)... , ... December 01, 2015 , ... Nurotron Biotechnology Co., ... its largest order to date. , The order will be from the China ... Venus Cochlear Implant System is an effective solution for children and adults suffering from ...
Breaking Medicine News(10 mins):