PARAMUS,
N.J, Aug. 1, 2024 /PRNewswire/
-- Octapharma USA, Inc. has
announced the expanded approval of fibryga®, Fibrinogen
(Human) Lyophilized Powder for Reconstitution, for fibrinogen
replacement in bleeding patients with acquired fibrinogen
deficiency (AFD) by the U.S. Food and Drug Administration (FDA). As
the first and only on-demand, virus-inactivated, human
plasma-derived fibrinogen concentrate option with this approval,
fibryga represents a rapid and more precise option for severe
bleeding scenarios than the current standard of care
(cryoprecipitate).
Fibrinogen plays an important role in coagulation and blood
clotting in emergency and surgical settings. Fibrinogen is the
first coagulation factor to drop to critically low levels during
severe bleeding episodes. Rapid replenishment of fibrinogen is
essential for achieving hemostasis in bleeding patients. Acquired
fibrinogen deficiency (AFD) often results from severe bleeding and
can impair blood clot formation, increasing the risk of ongoing
hemorrhage in patients. Cryoprecipitate, which was introduced in
1964, comes with significant drawbacks, including long thawing and
preparation processes, variable levels of fibrinogen, inclusion of
additional coagulation-dependent components, and a higher risk of
viral transmission. The approval of fibryga for AFD is a major
advancement from the current standard of care. As a lyophilized
powder, it can be stored at room temperature or refrigerated and
can be quickly reconstituted at the point of patient care. It's
precise and delivers a highly purified and consistent amount of
fibrinogen for accurate treatment.
"In the surgical theater, time matters. And confidence matters.
This expanded FDA approval of fibryga represents a major step
forward in our commitment to redefining the standard of care for
patients experiencing major bleeding. It provides an important
option for providers who must act urgently," said Flemming
Nielsen, President, Octapharma USA, Inc. "We are proud to be the first to
offer this therapeutic advancement—and a new standard of care—to
hospitals, anesthesiologists, surgeons, OB/GYNs, and patients
across the United States."
The expanded FDA approval of fibryga was based on the FIBRES
[FIBrinogen REplenishment in Surgery] study published in JAMA,
which was a head-to-head, multicenter, randomized clinical trial in
735 patients, demonstrating that fibrinogen concentrate was
non-inferior to cryoprecipitate and may be used instead of
cryoprecipitate for the treatment of bleeding related to AFD.
Fibryga has already received regulatory approval for the treatment
of AFD in both the European Union in 2019 and Canada in 2020.
Today's approval marks the third FDA approval received to date
for fibryga. In 2017, the FDA granted an approval for acute
bleeding episodes in adults and adolescents with congenital
fibrinogen deficiency, including afibrinogenemia and
hypofibrinogenemia. A second was received in 2020 for pediatric
patients under 12 years for treatment of acute bleeding episodes in
congenital fibrinogen deficiency.
"The recent FDA approval is the result of years of dedicated
research and development in fibrinogen replacement," commented Huub
Kreuwel, Ph.D., VP of Medical Affairs at Octapharma USA, Inc. "Fibryga's expanded indication will
allow practitioners and health systems to support a broader range
of patients with serious bleeding complications who require
fibrinogen replacement therapy."
The medical community has welcomed this approval as a
significant advancement in patient care for those with AFD. "This
first-in-class FDA approval for fibryga, a fibrinogen concentrate
with an expanded indication to treat bleeding patients urgently in
need of fibrinogen replacement, is an important step toward
improving patient safety and outcomes. Compared to cryoprecipitate,
fibrinogen concentrate allows for targeted dosing and faster
treatment of low fibrinogen in maternal hemorrhage," states
John Kowalczyk, MD, and Michaela Farber, MD, MS, Division of Obstetric
Anesthesia, Department of Anesthesiology, Perioperative and Pain
Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.
Octapharma is committed to working closely with healthcare
providers and patient organizations to ensure broad access to
fibryga for those who can benefit from it.
For more information about the FIBRES study, please review our
journal publication: Effect of Fibrinogen Concentrate vs
Cryoprecipitate on Blood Component Transfusion After Cardiac
Surgery The FIBRES Randomized Clinical Trial
Indications and Important Safety Information for
fibryga
Indications and Usage
Fibryga is a human
fibrinogen concentrate indicated for fibrinogen supplementation in
bleeding patients with acquired fibrinogen deficiency and in
treatment of acute bleeding episodes in patients with congenital
fibrinogen deficiency, including afibrinogenemia and
hypofibrinogenemia.
Fibryga is not indicated for dysfibrinogenemia.
Contraindications
Fibryga is contraindicated in
individuals who have manifested severe immediate hypersensitivity
reactions, including anaphylaxis, to fibryga or its components
(Sodium Citrate Dihydrate; Glycine; L-Arginine Hydrochloride).
Warnings and Precautions
Monitor patients for early
signs of hypersensitivity or allergic reactions. If necessary,
discontinue administration and institute appropriate treatment.
Thrombotic events have been reported in patients receiving
fibryga. Treatment with human fibrinogen concentrate has been
associated with thrombosis at target plasma fibrinogen levels that
were below 150 mg/dL. The thrombotic risks may be greater when the
target fibrinogen plasma level is 150 mg/dL. Weigh the benefits of
administration versus the risks of thrombosis.
Fibryga is made from pooled human plasma. Products made from
human plasma may contain infectious agents, e.g., viruses and,
theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
Adverse Reactions
The most serious adverse reactions
observed with fibryga are thromboembolic episodes and
anaphylactic-type reactions.
The most common adverse reactions observed in clinical studies
with fibryga in acquired fibrinogen deficiency (>5% of patients)
were abnormal hepatic function, acute kidney injury, anemia, atrial
fibrillation, delirium and renal failure.
The most common adverse reactions observed in clinical studies
with fibryga in congenital fibrinogen deficiency (>5% of
patients) were nausea, vomiting, pyrexia (fever) and
thrombocytosis.
Please see fibryga full Prescribing Information. For more
information about fibryga, please visit fibrygausa.com.
About Octapharma and Octapharma USA
Headquartered in Lachen,
Switzerland, Octapharma is one of
the largest human protein manufacturers in the world, developing
and producing human proteins from human plasma and human cell
lines.
Octapharma employs nearly 12,000 employees worldwide to support
the treatment of patients in 118 countries with products across
three therapeutic areas: Immunotherapy, Hematology, and Critical
Care.
Octapharma has seven R&D sites and five state-of-the-art
manufacturing facilities in Austria, France, Germany and Sweden, and operates more than 190 plasma
donation centers across Europe and
the US. Octapharma has 40 years of experience in patient care. The
company's American subsidiary, Octapharma USA, Inc., is located in Paramus, N.J. For more information, please
visit octapharmausa.com.
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