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:6/24/2016)... CAMBRIDGE, Mass. , June 24, 2016 /PRNewswire/ ... the Spaulding Rehabilitation Network,s Dean Center for ... of Physical Medicine and Rehabilitation, MIT Hacking Medicine, ... Center for Innovation, today announced the five finalists ... Hackathon for Lyme disease.  More than 100 scientists, ...
(Date:6/24/2016)... -- Dehaier Medical Systems Ltd. (NASDAQ: DHRM ... sells medical devices and wearable sleep respiratory products in ... agreement with Hongyuan Supply Chain Management Co., Ltd. (hereinafter ... 2016, to develop Dehaier,s new Internet medical technology business. ... leverage Hongyuan Supply Chain,s sales platform to reach Dehaier,s ...
(Date:6/24/2016)... , June 24, 2016   Pulmatrix, Inc ... company developing innovative inhaled drugs, announced today that it ... Russell Investments reconstituted its comprehensive set of U.S. ... "This is an important milestone for Pulmatrix," said ... increase shareholder awareness of our progress in developing drugs ...
Breaking Medicine Technology:
(Date:6/27/2016)... (PRWEB) , ... June 27, 2016 , ... "FCPX editors ... customizable inside of Final Cut Pro X," said Christina Austin - CEO of Pixel ... style. Final Cut Pro X users can now reveal the media of ...
(Date:6/27/2016)... ... June 27, 2016 , ... TopConsumerReviews.com recently awarded their highest five-star rating ... Millions of individuals in the United States and Canada wear eyeglasses. Once considered to ... correct vision and make a fashion statement. Even celebrities use glasses as a way ...
(Date:6/26/2016)... ... ... PawPaws brand pet supplements owned by Whole Health Supply is ... of felines. The formula is all-natural and is made from Chinese herbs that have ... Kidney Support Supplement Soft Chews are Astragalus Root Extract and Rehmannia Root Extract ...
(Date:6/25/2016)... ... June 25, 2016 , ... Austin residents seeking Mohs surgery services, can now ... and to Dr. Russell Peckham for medical and surgical dermatology. , Dr. Dorsey brings ... The selective fellowship in Mohs Micrographic Surgery completed by Dr. Dorsey was under the ...
(Date:6/25/2016)... ... ... As a lifelong Southern Californian, Dr. Omkar Marathe earned his Bachelors in ... School of Medicine at UCLA. He trained in Internal Medicine at Scripps Green Hospital ... at the UCLA-Olive View-Cedars Sinai program where he had the opportunity to train in ...
Breaking Medicine News(10 mins):