Baxter International Inc. (NYSE:BAX) and Halozyme Therapeutics, Inc.,
(NASDAQ:HALO) today announced that the Blood Products Advisory Committee
(BPAC) of the U.S. Food and Drug Administration (FDA) voted 15-1 that
HyQvia [Immune Globulin Infusion 10% (Human) with Recombinant Human
Hyaluronidase], Baxter’s investigational subcutaneous treatment for
patients with primary immunodeficiency (PI), has a favorable
risk/benefit profile.
HyQvia was approved in Europe in 2013 for adults (≥18 years) with
primary immunodeficiency syndromes and myeloma or chronic lymphocytic
leukaemia (CLL) with severe secondary hypogammaglobulinaemia and
recurrent infections.
Data presented at today’s advisory committee meeting included a review
of the preclinical and clinical data supporting the HyQvia application.
The FDA will consider the recommendation from the BPAC in its review of
Baxter’s amendment to the Biologics License Application (BLA) submitted
in December 2013. The company expects the FDA response in the third
quarter.
''We are hopeful that the positive support for HyQvia is the next step
toward providing a new treatment option for patients with primary
immunodeficiency in the United States. We look forward to working
closely with the FDA as it completes its review,'' said Ludwig Hantson,
Ph.D., president of Baxter BioScience.
''Today’s BPAC vote underscores the strength of the HyQvia data and our
rHuPH20 platform,'' commented Dr. Helen Torley, President and Chief
Executive Officer of Halozyme. ''Our rHuPH20 platform has been studied
in thousands of patients spanning multiple disease states and a number
of approved products.''
HyQvia was approved by the European Commission for EU member states in
2013 and is currently being prescribed in several European countries,
including Germany, Netherlands, Sweden, Norway, Denmark, Ireland and
Italy.
About HyQvia
HyQvia is a product consisting of human normal immunoglobulin (IG 10%)
and recombinant human hyaluronidase (licensed from Halozyme
Therapeutics). The IG provides the therapeutic effect and the
recombinant human hyaluronidase facilitates the dispersion and
absorption of the IG administered subcutaneously, increasing its
bioavailability. The IG is a 10% solution that is prepared from human
plasma consisting of at least 98% IgG, which contains a broad spectrum
of antibodies.
HyQvia is indicated in Europe as replacement therapy in adults (≥18
years) with primary immunodeficiency syndromes and in myeloma or chronic
lymphocytic leukaemia (CLL) with severe secondary hypogammaglobulinaemia
and recurrent infections.
Important Risk Information
HyQvia should not be used by patients with a hypersensitivity to human
immunoglobulins, especially in very rare cases of IgA deficiency when
the patient has antibodies against IgA. HyQvia should not be used by
patients with a systemic hypersensitivity to hyaluronidase or
recombinant human hyaluronidase. HyQvia should not be used by patients
with a hypersensitivity to any of the excipients, including glycine.
HyQvia must not be given intravenously.
HyQvia should not be used by women who are pregnant, or are planning to
become pregnant, or are breast-feeding.
Patients should be closely monitored and carefully observed for any
adverse reactions throughout the infusion period, particularly patients
starting with HyQvia treatment. In case of adverse reaction, either the
rate of administration must be reduced or the infusion stopped. The
treatment required depends on the nature and severity of the adverse
reaction. In case of shock, standard medical treatment for shock should
be implemented.
Thromboembolic events (e.g. myocardial infarction, cerebral vascular
accident, deep vein thrombosis, and pulmonary embolism), renal
dysfunction/failure, aseptic meningitis syndrome, and hemolysis have
been observed with IG 10% administered intravenously and cannot be
excluded with use of HyQvia. Thrombotic events and haemolysis have also
been reported in association with the subcutaneous administration of
immunoglobulin products.
Human normal immunoglobulin and human serum albumin (stabilizer of the
recombinant human hyaluronidase) are produced from human plasma and may
carry a risk of transmitting infectious agents.
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 pending regulatory review 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:
satisfaction of regulatory and other requirements; actions of regulatory
bodies and other governmental authorities; additional clinical results;
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