Navigation Links
CSL Behring Receives FDA Orphan Drug Designation for rVIIa-FP, a Novel Therapy in Development to Treat Hemophilia A and Hemophilia B Patients Who Have Inhibitors
Date:2/16/2012

ases that affect fewer than 200,000 people in the U.S. Orphan designation qualifies the sponsor of the product for important tax credits, elimination of FDA license application fees and certain marketing incentives.

CSL Behring's rVIIa-FP was granted Orphan Drug Designations (ODD) by the European Commission in May, 2011.

About Hemophilia
Hemophilia is a congenital bleeding disorder characterized by prolonged or spontaneous bleeding, especially into the muscles, joints, or internal organs. In nearly all cases, it affects only males. The disease is caused by deficient or defective blood coagulation proteins known as factor VIII or IX. The most common form of the disease is hemophilia A, or classic hemophilia, in which the clotting factor VIII is either deficient or defective.  Hemophilia B is characterized by deficient or defective factor IX. Hemophilia A affects approximately 1 in 5,000 to 10,000 people. Hemophilia B affects approximately 1 in 25,000 to 50,000 people. The recommended treatment for patients who are factor deficient is to treat by replacement factor therapy. A complication in some patients is the development of inhibitory antibodies (inhibitors) to FVIII or FIX which renders replacement therapy ineffective.  This can occur in up to 25 percent of hemophilia A patients and around 5 percent of hemophilia B patients.  One treatment option for these patients is recombinant activated factor VII (called a bypassing agent) which can be used to achieve hemostasis without the need for factor VIII or IX. 

About the recombinant fusion protein linking coagulation factor VIIa with albumin (rVIIa-FP)
Preclinical studies have confirmed that CSL Behring's rVIIa-FP has favorable pharmacokinetic properties compared with the existing recombinant FVIIa product.
'/>"/>

SOURCE CSL Behring
Copyright©2010 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2 3

Related medicine technology :

1. CSL Behring Receives FDA Approval of Expanded Label on Berinert® for Self-administration and Treatment of Acute Laryngeal Attacks of Hereditary Angioedema
2. CSL Behring Seeks Proposals for Interlaken Leadership Awards, Supporting Innovative Research Into Neuroimmunology
3. CSL Behring Receives EU Orphan Drug Designations for rVIIa-FP for Hemophilia A and B Treatment
4. National Organization for Rare Disorders Presents CSL Behring With 2011 Corporate Award
5. CSL Behring Marks World Hemophilia Day with Coagulation Factor Donation to World Federation of Hemophilia
6. CSL Behring Medical Product Donation Helps Meet Critical Need for Ongoing Cholera Relief Effort in Haiti
7. CSL Behring Announces Completion of National Marketing Authorizations of Berinert® After MRP in 23 European Countries
8. CSL Behring Announces FDA Approval of Berinert(R), First and Only Therapy Approved for the Treatment of Acute Abdominal and Facial Attacks of Hereditary Angioedema in U.S.
9. CSL Behring Receives Orphan-Drug Exclusivity for RiaSTAP(TM), First and Only Approved Treatment of Acute Bleeding Episodes in Patients with Congenital Fibrinogen Deficiency
10. Over $10 Million of CSL Behrings Privigen Was Sold in the U.S. During the Third Quarter of 2008
11. CSL Behring Submits BLA Requesting Approval of C1-Esterase Inhibitor for the Treatment of Hereditary Angioedema
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/17/2013)... , May 17, 2013  Lakeland Industries, Inc. (NASDAQ: ... protective clothing for industry, healthcare and to first responders ... its financial results for the fiscal 2013 fourth quarter ... 21, 2013 at stock market close and will conduct ... p.m. eastern. (Logo: http://photos.prnewswire.com/prnh/20120611/NY21959LOGO ) ...
(Date:5/17/2013)... N.C. , May 17, 2013  Technology ... organizations communicate internally. Faced with a constantly evolving ... strategies and tactics for communicating with internal executives. ... of all the strategies, tactics and tools that ... In a new study, Best Practices, LLC ...
(Date:5/17/2013)... , May 17, 2013  Sony Biotechnology Inc. ... SP6800 Spectral Analyzer (SP6800).  Sony will be exhibiting and ... will be held at the San Diego ... California , from May 20 - 22.  ... analytical system, incorporating commercial audio-visual technologies into new and ...
Breaking Medicine Technology:Lakeland Industries to Report Fiscal Fourth Quarter and Year End Financial Results and Conduct Conference Call 2Internal Communication Strategies and Tactics that Resonate with Key Stakeholders and Drive Organizational Effectiveness 2Sony Biotechnology Inc.'s New Technology for Science Provides Researchers Results in Color 2
... Treated for Acute Coronary Syndromes,(ACS) Nearly Triples the ... March 26, 2007 /PRNewswire/ -- One-year findings,from the ... patients in the "Angiomax(R) (bivalirudin) alone" treatment,group had ... complicated standard therapy, confirming previous findings,which showed similar ...
... CSL Limited today,announced results from a study published in ... of a novel new,drug, CSL-111, to acutely raise HDL ... the coronary arteries of,patients with a recent episode of ... to describe unstable angina and myocardial,infarction (heart attack). It ...
Cached Medicine Technology:Acuity One-Year Findings Meet All Primary Endpoints in Favor of,Angiomax (Bivalirudin) Alone Treatment Group 2Acuity One-Year Findings Meet All Primary Endpoints in Favor of,Angiomax (Bivalirudin) Alone Treatment Group 3Acuity One-Year Findings Meet All Primary Endpoints in Favor of,Angiomax (Bivalirudin) Alone Treatment Group 4Acuity One-Year Findings Meet All Primary Endpoints in Favor of,Angiomax (Bivalirudin) Alone Treatment Group 5Acuity One-Year Findings Meet All Primary Endpoints in Favor of,Angiomax (Bivalirudin) Alone Treatment Group 6CSL Therapy That Mimics 'Good' Cholesterol May Reduce Plaque Volume,in Coronary Arteries 2CSL Therapy That Mimics 'Good' Cholesterol May Reduce Plaque Volume,in Coronary Arteries 3CSL Therapy That Mimics 'Good' Cholesterol May Reduce Plaque Volume,in Coronary Arteries 4
(Date:5/19/2013)... 2013 Fat Burning Furnace developed by ... provides people with fat burning diet plans, ... Fat Burning Furnace package, people will receive the Fat ... download quickly. The Fat Burning Furnace manual includes fat ... lean muscle mass. In addition, this book covers step-by-step ...
(Date:5/19/2013)... 19, 2013 The Fat Loss Code program ... secrets that help people get in shape, and gain ... shape. The program also is a natural fat loss system ... the author of this fat loss diet program claimed that ... can help people keep body fat off long-term. After Shawn ...
(Date:5/19/2013)... 2013 Passages Malibu, the leading non-12 ... announced this week the launch of a “Sobriety, Health, ... media channels. “We are always looking for new ... to get feedback regarding sobriety, what’s working for people, ... of the Passages Addiction Treatment Centers located ...
(Date:5/19/2013)... Minor fender benders and serious car accidents are common ... accident to respond appropriately to the situation. According ... from 2010, accidents, including car accidents, are the fifth ... 2005, automobile accident-related deaths cost over $70 ... drivers and passengers receive treatment in an emergency room ...
(Date:5/18/2013)... 2013 Daily Gossip issued a press release ... on their page. John Colston, Daily Gossip’s spokesperson, told the ... revolutionizing 14-Day Rapid Fat Loss Plan . , ... are healthy at a time when nutritionists and fat loss ... products. , The diet is based on the ...
Breaking Medicine News(10 mins):Health News:Fat Burning Diet | How “Fat Burning Furnace” Helps People Lose Their Weight Naturally And Fast – V-kool 2Health News:Weight Loss Secrets | How “The Fat Loss Code” Helps People Gain A Healthy Life And Get In Shape - Health Review 2Health News:Passages Malibu Announces its Sobriety, Health, and Wellness Social Media Survey 2Health News:Passages Malibu Announces its Sobriety, Health, and Wellness Social Media Survey 3Health News:Auto Accident Infographic Issued by d’Oliveira & Associates on Steps to Take After a Car Crash 2
... Sniffing out a new source of stem cells ... at the Salk Institute for Biological Studies, La Jolla, has ... from immune system tissue in the smell-sensing region of the ... a source of cells to treat brain disorders in which ...
... researchers who studied controversial aspects of Medicare spending ... award yesterday from the nation,s largest health services ... presented its 2011 Article of the Year Award ... the Center for Outcomes Research at The Children,s ...
... learn about the signs and symptoms of drug impairment ... Sam Houston State University (SHSU) June 14. The free, ... after Sept. 1, 2011., The program, funded by the ... employers, including human resources personnel, owners and executive staff. ...
... in the United States are cancer survivors. On average, their ... care of people who have never had cancer, according to ... and survive cancer are susceptible to later health complications and ... are considered cancer survivors from the moment they are diagnosed ...
... an increased risk of adverse pregnancy outcomes, suggests a ... in Minneapolis, Minn., at SLEEP 2011, the 25th Anniversary ... Results show that women with severe sleep apnea ... This increased prevalence was principally driven by a higher ...
... developed a tool to rapidly assess the risk of ... on psychiatric units. Ultimately, they hope to use ... behavior in schools and in the community. A ... the Child and Adolescent Aggression (BRACHA) tool is published ...
Cached Medicine News:Health News:JCI online early table of contents: June 13, 2011 2Health News:JCI online early table of contents: June 13, 2011 3Health News:JCI online early table of contents: June 13, 2011 4Health News:JCI online early table of contents: June 13, 2011 5Health News:JCI online early table of contents: June 13, 2011 6Health News:JCI online early table of contents: June 13, 2011 7Health News:JCI online early table of contents: June 13, 2011 8Health News:JCI online early table of contents: June 13, 2011 9Health News:JCI online early table of contents: June 13, 2011 10Health News:Hospital outcomes research named 'Article of the Year' 2Health News:Hospital outcomes research named 'Article of the Year' 3Health News:Drug recognition program available for Texas employers 2Health News:Cancer survivors spend more on health care 2Health News:Sleep apnea may increase the risk of adverse pregnancy outcomes 2Health News:Tool developed to predict violence and aggression in children and teens 2
... designed to meet the working and budgetary ... user to run set assays at the ... on this strip washer adjusts to wash ... Reliable, compact, and self-contained, offers aerosol and ...
... Labcyte miniGene LW is a new plate washing ... 96 and 384 channel microplates with flat, V-shaped ... with 8 or 16 channel nozzle heads. Simple ... breeze. An optional plate stacker is available for ...
... L/day of Type III Laboratory-grade Water, RiOs ... up to 8000 L/day of Type III ... Complete Purification and Control Unit, RiOs systems ... providing total control of all parameters within ...
... Produce Up to 8000 L/day of ... systems are designed to produce up to ... from potable tap feedwater., One Complete Purification ... integrated into a centralized system, providing total ...
Medicine Products: