Navigation Links
CSL Behring Announces FDA Filing of Biologics License Application for 4-Factor PCC for Urgent Reversal of Vitamin K Antagonist Anticoagulant Therapy
Date:5/29/2012

KING OF PRUSSIA, Pa., May 29, 2012 /PRNewswire/ -- CSL Behring today announced that the U.S. Food and Drug Administration (FDA) has accepted for standard review its Biologics License Application (BLA) for a human 4-factor prothrombin complex concentrate (PCC) for the urgent reversal of vitamin K-antagonist therapy (i.e., warfarin) in patients with acute major bleeding. If approved by the FDA, the CSL Behring 4-factor PCC would be the first agent of its kind available in the United States.

"The acceptance by FDA of this 4-factor PCC BLA marks an important step toward addressing the urgent unmet need for a rapid and simple way to reverse the effects of warfarin during bleeding emergencies," said Val Romberg, Senior Vice President, Research and Development at CSL Behring. "This 4-factor PCC has the potential to be a significant new tool in stopping excessive bleeding in patients on warfarin, where fresh frozen plasma is the current standard of care."

The CSL Behring BLA submission is based on results from three prospective Phase III clinical trials that evaluated the safety and efficacy of PCC in patients who required urgent reversal of warfarin therapy. The pivotal, acute major bleeding trial demonstrated that PCC was comparable to plasma at 24 hours in patients who required urgent reversal of warfarin therapy (72.4 percent and 65.4 percent, respectively). Additionally, the co-primary efficacy endpoint analysis showed that the 4-factor PCC was superior in achieving target INR correction within 30 minutes at the end of infusion as compared to plasma (62.2 percent and 9.6 percent, respectively). Four-factor PCC was also superior to plasma in rapidly and safely raising the levels of clotting factors II, VII, IX, X, and anticoagulant Proteins C and S at the same 30 minutes post-treatment time point (p values<0.0001).

About Prothrombin Complex Concentrate (PCC) (Human)

Prothrombin compl
'/>"/>

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

Page: 1 2 3

Related medicine technology :

1. CSL Behring Initiates Study of Subcutaneous Administration of C1-esterase Inhibitor in Patients with Hereditary Angioedema
2. CSL Behring Renews Pledge to Provide Significant Funding and Donated Coagulation Factor to World Federation of Hemophilia Over 3-Year Period
3. CSL Behring Announces First Patient Treated in Phase III Study of Fibrinogen Concentrate (Human)(FCH) to Control Bleeding During Aortic Aneurysm Surgery
4. CSL Behring Recognized as a "Pioneer" By European Organisation for Rare Diseases (EURORDIS)
5. First Patient Screened in CSL Behring Global Phase I/III Study of Recombinant Single-Chain Factor VIII
6. 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
7. CSL Behring Receives FDA Approval of Expanded Label on Berinert® for Self-administration and Treatment of Acute Laryngeal Attacks of Hereditary Angioedema
8. CSL Behring Seeks Proposals for Interlaken Leadership Awards, Supporting Innovative Research Into Neuroimmunology
9. CSL Behring Receives EU Orphan Drug Designations for rVIIa-FP for Hemophilia A and B Treatment
10. National Organization for Rare Disorders Presents CSL Behring With 2011 Corporate Award
11. CSL Behring Marks World Hemophilia Day with Coagulation Factor Donation to World Federation of Hemophilia
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/20/2014)... 20, 2014 Torrance Memorial Medical Center ... ventilator technology from Covidien to provide a simple, ... The acute care ventilator is designed ... conventional mechanical ventilation, and help clinicians move patients ... on mechanical ventilation are often sedated to ease ...
(Date:8/20/2014)... 20, 2014 Children aren,t the only ... to help prevent disease. The Centers for Disease ... adults, but currently, many adults are not following ... Immunization Awareness Month, and the American Lung Association ... those with lung disease, to talk with their ...
(Date:8/20/2014)... 20, 2014 Research and Markets  has announced ... report to their offering. Global Market ... on Pralmorelin globally and regionally ( Europe , ... , Latin America etc.). It captures ... This report focuses on three primary areas; manufacture methods & ...
Breaking Medicine Technology:Torrance Memorial Medical Center Acquires Advanced Ventilator Technology to Enhance Patient Care 2American Lung Association Urges Adults with Lung Disease to Consult their Health Care Provider to Stay Current on Vaccinations 2American Lung Association Urges Adults with Lung Disease to Consult their Health Care Provider to Stay Current on Vaccinations 3Global Market Report of Pralmorelin 2
... for Safe Biologic Medicines will have an open ... on biologic medicines and pharmacovigilance.  Dr. Richard Dolinar, a practicing ... newly released FDA draft guidances for manufacturers of ... it and why is it important?  will ...
... MusculoskeletalNetwork , an online resource for ... now features a summary of the key orthopedic findings ... Academy of Orthopaedic Surgeons ( AAOS ) this February ... offers orthopedists a comprehensive program with the latest in ...
Cached Medicine Technology:Alliance for Safe Biologic Medicines Announces New Webinar on February 16 2UBM Medica's Musculoskeletal Network Highlights Key Orthopedic Findings From AAOS 2UBM Medica's Musculoskeletal Network Highlights Key Orthopedic Findings From AAOS 3
(Date:8/20/2014)... The Board of Directors of top international ... pleased to announce the expansion of its healthcare ... and the surrounding region. In support of this strategic ... has relocated to the firm’s office in Shanghai, China, ... design and to better support regional clients. , ...
(Date:8/20/2014)... persistent and deadliest infectious diseases in the world, killing ... who study tuberculosis have long debated its origins. New ... Africa to seals and sea lions that brought the ... people there before Europeans landed on the continent. , ... Source of New World Human Tuberculosis," was published in ...
(Date:8/20/2014)... to spawning grounds through fast-moving waters may be at ... scientists. , When salmon encounter turbulent, fast-moving water ... they must move upstream using a behaviour known as ... , "Days after sockeye passed through extremely fast-moving water, ... distance from their spawning grounds," said Nicholas Burnett, a ...
(Date:8/20/2014)... New York (PRWEB) August 20, 2014 ... the use of power morcellators ( http://www.injurybeacon.com/power-morcellator/ ) ... notes that two U.S. Senators from New York are ... seek a recall of the devices. In a letter ... both Democrats, also implored the agency to seriously consider ...
(Date:8/20/2014)... NEW YORK, NY (August 20, 2014) Research from ... a critical role in stomach cancer growth and that ... be an effective treatment for the disease. The study ... MD, in collaboration with Duan Chen, MD, PhD, in ... Science Translational Medicine . , "Scientists have long observed ...
Breaking Medicine News(10 mins):Health News:Perkins Eastman Expands Presence in China 2Health News:Perkins Eastman Expands Presence in China 3Health News:New research shows seals and sea lions likely spread tuberculosis to humans 2Health News:New research shows seals and sea lions likely spread tuberculosis to humans 3Health News:Salmon forced to 'sprint' less likely to survive migration 2Health News:Power Morcellator News: Bernstein Liebhard LLP Notes Senators’ Letter Seeking FDA Morcellator Recall 2Health News:Power Morcellator News: Bernstein Liebhard LLP Notes Senators’ Letter Seeking FDA Morcellator Recall 3Health News:Power Morcellator News: Bernstein Liebhard LLP Notes Senators’ Letter Seeking FDA Morcellator Recall 4Health News:Severing nerves may shrink stomach cancers: Botox injections slow growth of tumors in mice 2
... Conn.Yale School of Medicine is hosting a two-day symposium Nov. ... the late actor John Ritter, who died of an aortic ... Diseases: Lux et Veritas will be held in Mary S. ... program is John Elefteriades, M.D., section chief of cardiothoracic surgery ...
... the United States via Haiti, probably arriving in just one ... new research. , After the virus, HIV-1, entered the ... results show that the strain of virus that spawned the ... is earlier than a lot of people had imagined," said ...
... and Asia are born and die without leaving a ... little information on which to base public health decisions, ... and colleagues say in a paper published today (Oct. ... , However, affordable solutions exist to collect these vital ...
... study finds it can prevent or shorten the illness , ... in the blood may help prevent pneumonia in elderly nursing ... at Tufts University looked at 617 people 65 and older ... found that those with normal blood zinc concentrations were about ...
... National Campaign to Inspire and ... Educate that Prevention is Possible, BERKELEY, Calif., Oct. 29 ... lifetime. Although 50 percent,of women think breast cancer is hereditary, only ... disease. LUNA, the makers of whole nutrition bars for women(R), ...
... patients with Philadelphia, chromosome-positive chronic myeloid leukemia resistant or intolerant to ... ... Novartis can offer physicians and patients a ... Tasigna(R),(nilotinib) capsules have been approved in the US as a new ...
Cached Medicine News:Health News:HIV's path out of Africa: Haiti, the US then the world 2Health News:HIV's path out of Africa: Haiti, the US then the world 3Health News:Scandal of invisibility plagues countries with no civil registries 2Health News:Scandal of invisibility plagues countries with no civil registries 3Health News:Zinc Helps Elderly Ward Off Pneumonia 2Health News:LUNA Pure Prevention Survey Confirms Breast Cancer Misconceptions 2Health News:LUNA Pure Prevention Survey Confirms Breast Cancer Misconceptions 3Health News:Video and Photo: Tasigna(R) Receives US Approval Providing New Hope to Chronic Myeloid Leukemia Patients With Resistance or Intolerance to Existing Therapies 2Health News:Video and Photo: Tasigna(R) Receives US Approval Providing New Hope to Chronic Myeloid Leukemia Patients With Resistance or Intolerance to Existing Therapies 3Health News:Video and Photo: Tasigna(R) Receives US Approval Providing New Hope to Chronic Myeloid Leukemia Patients With Resistance or Intolerance to Existing Therapies 4Health News:Video and Photo: Tasigna(R) Receives US Approval Providing New Hope to Chronic Myeloid Leukemia Patients With Resistance or Intolerance to Existing Therapies 5Health News:Video and Photo: Tasigna(R) Receives US Approval Providing New Hope to Chronic Myeloid Leukemia Patients With Resistance or Intolerance to Existing Therapies 6Health News:Video and Photo: Tasigna(R) Receives US Approval Providing New Hope to Chronic Myeloid Leukemia Patients With Resistance or Intolerance to Existing Therapies 7Health News:Video and Photo: Tasigna(R) Receives US Approval Providing New Hope to Chronic Myeloid Leukemia Patients With Resistance or Intolerance to Existing Therapies 8Health News:Video and Photo: Tasigna(R) Receives US Approval Providing New Hope to Chronic Myeloid Leukemia Patients With Resistance or Intolerance to Existing Therapies 9Health News:Video and Photo: Tasigna(R) Receives US Approval Providing New Hope to Chronic Myeloid Leukemia Patients With Resistance or Intolerance to Existing Therapies 10
... Endoscopic CycloPhotocoagulation (ECP) is a surgical ... endoscopy and visualized laser application. The ciliary ... by the surgeon, from the anterior or ... time. The target tissues are easily and ...
... German Craftsmanship have produced the ... world. Ocutek® now makes them ... of the coveted Meisterbrief certificate, ... are qualified to become Ocutek ...
... Centuries of German Craftsmanship ... instrumentation in the world. Ocutek® ... you! Only holders of the ... and eight-year apprenticeship, are qualified ...
... German Craftsmanship have produced the ... world. Ocutek® now makes them ... of the coveted Meisterbrief certificate, ... are qualified to become Ocutek ...
Medicine Products: