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:2/5/2016)... -- ivWatch, a medical devices company, is one of five recipients ... Terry McAuliffe,s office. ivWatch will be receiving the ... event to be held at the Science Museum of ... business that have made significant contributions to science. ... ...
(Date:2/5/2016)... -- Aralez Pharmaceuticals Inc. ("Aralez") today announced the completion of ... Canada Inc. ("Tribute") following approval of the transaction by ... company will operate under Aralez Pharmaceuticals Inc. ("Aralez"), a ... Canada , Ireland and ... terms of the Agreement and Plan of Merger and ...
(Date:2/5/2016)... Feb. 5, 2016  Venice,s newest laser clinic, ... first of its kind in the area and ... advanced laser treatment. The physician-owned and operated laser ... Suncoast by storm with its revitalizing skin care ... multi-wavelength Astanza Trinity technology. http://photos.prnewswire.com/prnh/20160204/329957 ...
Breaking Medicine Technology:
(Date:2/8/2016)... ... , ... Delta Dental of California and its affiliated companies announced today that ... who recently retired as president and CEO of Delta Dental of California and its ... Year , helped lead the effort to raise funds for studies to strengthen pancreatic ...
(Date:2/8/2016)... ... February 08, 2016 , ... Discover the Rocky Mountain ... 1,400 booths and 700 companies. Attendees also get to see the most incredible ... Garden & Home Show , at the Colorado Convention Center - 700 14th St. ...
(Date:2/8/2016)... ... ... Guruji Mahendra Kumar Trivedi is offering 3 days of accelerated personal growth ... on February 10th. During this time, people can achieve better health, greater wealth, ... from over 40 different countries as an “ordinary man with an extraordinary gift.” ...
(Date:2/7/2016)... ... February 07, 2016 , ... HealthSmart ... employers and organizations with the tools and information to lower the costs, and ... cut the cost of providing employee healthcare benefits by as much as 22%:, ...
(Date:2/6/2016)... , ... February 06, 2016 , ... Shark Finds ... announce the launch of a new DRTV campaign with Belly Bands. , Having a ... everything from sprays to puppy pads and find nothing works, get Belly Bands, ...
Breaking Medicine News(10 mins):