Baxter International Inc. (NYSE:BAX) and Halozyme Therapeutics,
Inc., (NASDAQ:HALO) today announced the launch and first shipments
of HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant
Human Hyaluronidase], Baxter’s subcutaneous immunoglobulin
treatment for adult patients with primary immunodeficiency (PI) in
the United States. The treatment was approved by the U.S. Food and
Drug Administration (FDA) in September of this year.
''HYQVIA will have a significant impact on the treatment of
primary immunodeficiency. It will be a welcomed addition to the
therapeutic options in my practice, particularly for patients who
are seeking less frequent dosing, but still desire the efficacy and
tolerability associated with subcutaneous treatment,'' said Richard
L. Wasserman, M.D., Ph.D, clinical professor of pediatrics at
University of Texas Southwestern Medical School and clinical
investigator on the HYQVIA clinical trial.
HYQVIA is the first subcutaneous immune globulin (IG) treatment
approved for adult PI patients that allows a full monthly dose of
IG to be administered with only one injection site and one infusion
each month (once every three to four weeks depending on their
established dosing regimen).
''With our swift commercial introduction, we look forward to
sharing HYQVIA with adult PI patients seeking an option with less
frequent dosing than current subcutaneous treatments without
compromising efficacy, safety and tolerability. The goal of HYQVIA
is to allow people with PI to feel less like patients by reducing
the treatment burden associated with weekly dosing and multiple
injection sites per dose,'' said Ludwig Hantson, Ph.D., President
of Baxter BioScience.
HYQVIA was approved in Europe in 2013 for adults (≥18 years)
with primary immunodeficiency syndromes and myeloma or chronic
lymphocytic leukemia (CLL) with severe secondary
hypogammaglobulinemia and recurrent infections. It is currently
available in several European countries, including Germany,
Netherlands, Sweden, Norway, Denmark, Ireland and Italy.
About HYQVIA
HYQVIA is an immune globulin with a recombinant human
hyaluronidase indicated for the treatment of Primary
Immunodeficiency (PI) in adults.
HYQVIA is a product consisting of Immune Globulin Infusion 10%
(Human) (IG 10%) and recombinant human hyaluronidase (developed by
Halozyme Therapeutics).
The IG component, a 10% solution that is prepared from large
pools of human plasma consisting of at least 98% IgG, contains a
broad spectrum of antibodies and provides the therapeutic effect.
The Recombinant Human Hyaluronidase of HYQVIA increases dispersion
and absorption of the Immune Globulin Infusion 10% (Human).
Important Risk Information
Thrombosis may occur with immune globulin products, including
HYQVIA. Risk factors may include advanced age, prolonged
immobilization, hypercoagulable conditions, history of venous or
arterial thrombosis, use of estrogens, indwelling vascular
catheters, hyperviscosity, and cardiovascular risk factors.
Thrombosis may occur in the absence of known risk factors. For
patients at risk of thrombosis, administer HYQVIA at the minimum
dose and infusion rate practicable. Ensure adequate hydration in
patients before administration. Monitor for signs and symptoms of
thrombosis and assess blood viscosity in patients at risk of
hyperviscosity.
HYQVIA is contraindicated in patients who have a history of
anaphylactic or severe systemic reactions to the administration of
IgG; in IgA-deficient patients with antibodies to IgA and a history
of hypersensitivity; and in patients with known systemic
hypersensitivity to hyaluronidase or Recombinant Human
Hyaluronidase of HYQVIA. Severe hypersensitivity reactions may
occur, even in patients who have tolerated previous treatment with
IgG. Patients with antibodies to IgA are potentially at greater
risk of developing potentially severe hypersensitivity and
anaphylactic reactions. Non-neutralizing antibodies to the
recombinant human hyaluronidase component may develop. The
potential exists for such antibodies to cross-react with endogenous
PH20, which is known to be expressed in adult male testes,
epididymis, and sperm. It is unknown whether these antibodies may
interfere with fertilization in humans. The clinical significance
of these antibodies is unknown.
Aseptic Meningitis Syndrome (AMS) has been reported to occur
with IgG products, including Immune Globulin Infusion 10% (Human)
administered intravenously and subcutaneously. Discontinuation of
IgG treatment has resulted in remission of AMS within several days
without sequelae. The syndrome usually begins within several hours
to two days following intravenously administered IgG, perhaps more
frequently in association with high dose (2 g/kg) intravenously
administered IgG.
IgG products, including HYQVIA, contain blood group antibodies
which may act as hemolysins and induce in vivo coating of red
blood cells (RBC) with IgG. These antibodies may cause a positive
direct antiglobulin reaction and hemolysis. Acute intravascular
hemolysis has been reported following intravenously administered
IgG, including Immune Globulin Infusion 10% (Human) administered
intravenously, and delayed hemolytic anemia can develop due to
enhanced RBC sequestration.
Acute renal dysfunction/failure, acute tubular necrosis,
proximal tubular nephropathy, osmotic nephrosis, and death may
occur upon use of IgG products administered intravenously,
especially those containing sucrose. HYQVIA does not contain
sucrose. Periodic monitoring of renal function and urine output is
particularly important in patients judged to be at increased risk
for developing acute renal failure.
Infusion into or around an infected area can spread a localized
infection. Do not infuse HYQVIA into these areas due to potential
risk of spreading a localized infection. Non-cardiogenic pulmonary
edema (TRALI) may occur with intravenously administered IgG and has
been reported to occur with Immune Globulin Infusion 10% (Human)
administered intravenously. TRALI is characterized by severe
respiratory distress, pulmonary edema, hypoxemia, normal left
ventricular function, and fever.
Because the Immune Globulin Infusion 10% (Human) of HYQVIA is
made from human plasma, it may carry a risk of transmitting
infectious agents, e.g., viruses, the variant CJD (vCJD) agent, and
theoretically, the Creutzfeldt-Jakob disease (CJD) agent. This also
applies to unknown or emerging viruses and other pathogens. No
cases of viral transmission or CJD have been associated with
HYQVIA.
After infusion of IgG, the transitory rise of the various
passively transferred antibodies in the patient’s blood may yield
false positive serological testing results, with the potential for
misleading interpretation. Passive transmission of antibodies to
erythrocyte antigens (e.g., A, B, and D) may cause a positive
direct or indirect antiglobulin (Coombs’) test.
Common adverse reactions observed in clinical trials in >5%
of subjects were: local reactions, headache, antibody formation
against recombinant human hyaluronidase (rHuPH20), fatigue, nausea,
pyrexia, and vomiting.
Please see accompanying full prescribing information,
including boxed warning for HYQVIA at:
http://www.baxter.com/downloads/healthcare_professionals/products/HYQVIA_PI.pdf.
About Baxter International Inc.
Baxter International Inc., through its subsidiaries, develops,
manufactures and markets products that save and sustain the lives
of people with hemophilia, immune disorders, cancer, infectious
diseases, kidney disease, trauma and other chronic and acute
medical conditions. As a global, diversified healthcare company,
Baxter applies a unique combination of expertise in medical
devices, pharmaceuticals and biotechnology to create products that
advance patient care worldwide.
About Halozyme Therapeutics
Halozyme Therapeutics is a biopharmaceutical company dedicated
to developing and commercializing innovative products that advance
patient care. With a diversified portfolio of enzymes that target
the extracellular matrix, the Company's research focuses primarily
on a family of human enzymes, known as hyaluronidases, which
increase the absorption and dispersion of biologics, drugs and
fluids. Halozyme\'s pipeline addresses therapeutic areas, including
oncology, diabetes, and dermatology that have significant unmet
medical need. The Company markets Hylenex® recombinant
(hyaluronidase human injection) and has partnerships with Roche,
Pfizer, and Baxter. Halozyme is headquartered in San Diego. For
more information on how we are innovating, please visit our
corporate website at www.halozyme.com.
This release includes forward-looking statements concerning
HYQVIA, including expectations with regard to its impact to
patients. The statements are based on assumptions about many
important factors, including the following, which could cause
actual results to differ materially from those in the
forward-looking statements: actions of regulatory bodies and other
governmental authorities; satisfaction of regulatory and other
requirements; changes in laws and regulations; product quality or
supply or patient safety issues; and other risks identified in
Baxter's most recent filing on Form 10-K and other SEC filings, all
of which are available on Baxter's website. Baxter does not
undertake to update its forward-looking statements.
Baxter Media ContactBrian Kyhos,
224-948-5353media@baxter.comorBaxter Investor ContactsMary
Kay Ladone, 224-948-3371Clare Trachtman, 224-948-3085orHalozyme
Media / Investor ContactSchond Greenway,
858-704-8352ir@halozyme.com
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