KING OF PRUSSIA, Pa.,
March 17, 2015 /PRNewswire/ -- CSL
Behring today announced that The Lancet has published
results from a Phase III clinical study showing
Kcentra® (Prothrombin Complex Concentrate
[Human]) to be superior to plasma for the urgent reversal of
acquired coagulation factor deficiency induced by vitamin K
antagonist (VKA, e.g., warfarin) therapy in adult patients needing
an urgent surgery or invasive procedure.
Kcentra is the first and only non-activated
4-factor prothrombin complex concentrate (4F-PCC) approved by the
U.S. Food and Drug Administration (FDA) for this use and for the
urgent reversal of warfarin therapy in adult patients with acute
major bleeding.
Each year, approximately three to four million people in the
U.S. use warfarin to prevent blood clots from forming following a
stroke, heart attack, heart valve surgery, deep vein
thrombosis/pulmonary embolism, or certain types of irregular
heartbeat, such as atrial fibrillation.1,2 Due to a
deficiency in blood clotting factors induced by warfarin treatment,
patients are at increased risk of bleeding, especially if
undergoing an urgent surgery or invasive procedure.
"The results of the Phase III study published in The
Lancet show that Kcentra is more effective than plasma
for INR [international normalized ratio] reduction and
periprocedural hemostasis in adults who are taking warfarin and
require an urgent procedure," said lead study author Joshua N. Goldstein, M.D., Ph.D., attending
physician in the Department of Emergency Medicine at Massachusetts
General Hospital.
Results of the multicenter, open-label, phase IIIb randomized
trial showed that in 168 evaluable patients, 90 percent of patients
treated with Kcentra achieved effective hemostasis,
compared to 75 percent of patients treated with plasma.
Additionally, INR reduction to ≤1.3 at 30 minutes after the end of
infusion was achieved in 55 percent of patients treated with
Kcentra versus 10 percent of patients treated with plasma.
Incidences of adverse events, serious adverse events,
thromboembolic events, and deaths were similar between the
Kcentra and plasma groups. In post-hoc analysis, the median
time from start of infusion to start of urgent surgical procedure
was shorter in the Kcentra group (3.6 hours [IQR 1.9–10.8])
than in the plasma group (8.5 hours [IQR 2.8–18.7]);
(p=0.0098).
"CSL Behring has long been at the forefront of developing
innovative protein therapies to help healthcare professionals treat
patients with serious medical conditions," said Bill Campbell, Senior Vice President, North
America Commercial Operations, CSL Behring. "Kcentra further
underscores our commitment by providing physicians with a treatment
option to prevent and manage the risks of excessive bleeding in
patients on warfarin who need to undergo an urgent surgery or
invasive procedure."
Kcentra was first approved for use in the U.S. in April
2013 and received a new technology add-on payment (NTAP)
designation from the Centers for Medicare and Medicaid Services
through September 2015. To be eligible for an NTAP, the product
must be new and inadequately paid for under existing MS-DRGs, and
must provide a significant clinical improvement over existing
therapies.
About Kcentra®
In more
than 25 countries, CSL Behring markets Kcentra as
Beriplex® or Confidex®. In
December 2012, the FDA granted Orphan
Drug Designation to Kcentra for the treatment of patients
needing urgent reversal of Vitamin K antagonist therapy due to
major bleeding and/or surgical procedures. The FDA's Orphan Drug
Designation program provides orphan status to drugs and biologics
defined as those intended for the safe and effective treatment or
prevention of rare diseases 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.
Important Safety Information
Kcentra®, Prothrombin Complex Concentrate
(Human), is a blood coagulation factor replacement product
indicated for the urgent reversal of acquired coagulation factor
deficiency induced by Vitamin K antagonist (VKA—e.g., warfarin)
therapy in adult patients with acute major bleeding or the need for
urgent surgery or other invasive procedure. Kcentra is for
intravenous use only.
WARNING: ARTERIAL AND VENOUS THROMBOEMBOLIC
COMPLICATIONS
Patients being treated with Vitamin K antagonist therapy have
underlying disease states that predispose them to thromboembolic
events. Potential benefits of reversing VKA should be weighed
against the risk of thromboembolic events, especially in patients
with history of such events. Resumption of anticoagulation therapy
should be carefully considered once the risk of thromboembolic
events outweighs the risk of acute bleeding. Both fatal and
nonfatal arterial and venous thromboembolic complications have been
reported in clinical trials and postmarketing surveillance. Monitor
patients receiving Kcentra, and inform them of signs and symptoms
of thromboembolic events. Kcentra was not studied in subjects who
had a thromboembolic event, myocardial infarction, disseminated
intravascular coagulation, cerebral vascular accident, transient
ischemic attack, unstable angina pectoris, or severe peripheral
vascular disease within the prior three months. Kcentra might not
be suitable for patients with thromboembolic events in the prior
three months.
Kcentra is contraindicated in patients with known
anaphylactic or severe systemic reactions to Kcentra or any
of its components (including heparin, Factors II, VII, IX, X,
Proteins C and S, Antithrombin III and human albumin).
Kcentra is also contraindicated in patients with
disseminated intravascular coagulation. Because Kcentra
contains heparin, it is contraindicated in patients with
heparin-induced thrombocytopenia (HIT).
Hypersensitivity reactions to Kcentra may occur. If
patient experiences severe allergic or anaphylactic type reactions,
discontinue administration and institute appropriate
treatment.
In clinical trials, the most frequent (≥2.8%) adverse reactions
observed in subjects receiving Kcentra were headache,
nausea/vomiting, hypotension, and anemia. The most serious adverse
reactions were thromboembolic events, including stroke, pulmonary
embolism and deep vein thrombosis.
Kcentra is derived from human plasma. The risk of
transmission of infectious agents, including viruses and,
theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be
completely eliminated.
The safety and efficacy of Kcentra in pediatric use have
not been studied, and Kcentra should be used in women who
are pregnant or nursing only if clearly needed.
For more information about Kcentra, please visit
www.kcentra.com or call toll-free 1-855-4KCENTRA. For full
prescribing information, please visit
www.kcentra.com/prescribing-information.aspx.
About CSL Behring
CSL Behring is a leader in the
plasma protein therapeutics industry. Committed to saving lives and
improving the quality of life for people with rare and serious
diseases, the company manufactures and markets a range of
plasma-derived and recombinant therapies worldwide.
CSL Behring therapies are used around the world to treat
coagulation disorders including hemophilia and von Willebrand
disease, primary immune deficiencies, hereditary angioedema and
inherited respiratory disease, and neurological disorders in
certain markets. The company's products are also used in cardiac
surgery, organ transplantation, burn treatment and to prevent
hemolytic disease of the newborn.
CSL Behring operates one of the world's largest plasma
collection networks, CSL Plasma. CSL Behring is a global
biopharmaceutical company and a member of the CSL Group of
companies. The parent company, CSL Limited (ASX: CSL), is
headquartered in Melbourne,
Australia. For more information, visit
www.cslbehring.com.
Contact:
Greg Healy
CSL Behring
Office: 610-878-4841
Mobile: 610-906-4564
Greg.Healy@CSLBehring.com
1 Zareh M, Davis A, Henderson S. Reversal of
warfarin-induced hemorrhage in the emergency department. West J
Emerg Med. 2011;12(4):386-392.
2 Raife TJ, Rose JS, Lentz SR. Bleeding from
acquired coagulation defects and antithrombotic therapy. In: Simon
TL, Snyder EL, Stowell CP, Strauss RG, Solheim BG, Petrides M, eds.
Rossi's Principles of Transfusion Medicine. 4th ed.
Hoboken, NJ: Wiley Blackwell; 2009; chapter 24.
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SOURCE CSL Behring