Baxter International Inc. (NYSE:BAX) and Halozyme Therapeutics, Inc.,
(NASDAQ:HALO) today announced that the United States Food and Drug
Administration (FDA) approved Baxter’s subcutaneous treatment for adult
patients with primary immunodeficiency (PI), HYQVIA [Immune Globulin
Infusion 10% (Human) with Recombinant Human Hyaluronidase].
HYQVIA is the first subcutaneous immune globulin (IG) treatment approved
for PI patients with a dosing regimen requiring only one infusion up to
once per month (every three to four weeks) and one injection site per
infusion to deliver a full therapeutic dose of IG. The majority of PI
patients today receive intravenous infusions in a doctor’s office or
infusion center, and current subcutaneous IG treatments require weekly
or bi-weekly treatment with multiple infusion sites per treatment.
''Patients with PI value treatments that offer efficacy, safety and
tolerability. Since each person with PI responds differently to
treatment, having options that meet these individual needs is critically
important,'' commented Marcia Boyle, President and Founder of the Immune
Deficiency Foundation. ''We commend Baxter for its significant
commitment and investment in the development of HYQVIA.''
''The availability of HYQVIA has a significant impact on the treatment
of PI, allowing for effective delivery of a full therapeutic dose of IG
less frequently than other subcutaneous treatments (up to once a month),
while maintaining the efficacy, safety and tolerability profile that is
most important for patients,'' said Ludwig Hantson, Ph.D., President of
Baxter BioScience. ''This approval highlights the support of the patient
community for new treatment options.''
''Today’s FDA approval of HYQVIA is a significant milestone for Halozyme
as it represents the first U.S. approved Biologics License Application
which utilizes our rHuPH20 platform,'' commented Dr. Helen Torley,
President and Chief Executive Officer of Halozyme. ''I would like to
thank the talented teams at both Halozyme and Baxter for their
dedication to bring a new treatment alternative to PI patients managing
a life-long disease.''
Baxter expects to launch HYQVIA in the U.S. in the coming weeks. 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 being prescribed 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 planned commercial launch in
the US. 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 each of the company's most recent filings on Form 10-K and
other SEC filings, all of which are available on their respective
websites. Neither Baxter nor Halozyme undertakes to update its
forward-looking statements.
Copyright Business Wire 2014