- HyQvia (Human Normal Immunoglobulin
(10%), Recombinant Human Hyaluronidase) is the only subcutaneous IG
treatment for primary and certain secondary immunodeficiencies that
can be administered in one site, once a month (up to every four
weeks)
- Product information now includes
indication to treat both adult and pediatric patients with this
challenging chronic disease
- Baxalta continues to build its
leadership in the primary immunodeficiency (PI) community by
expanding access to innovative treatments with the goal of reducing
burden for patients around the world
NOT FOR U.S. AUDIENCES
Baxalta Incorporated (NYSE:BXLT), a global biopharmaceutical
leader dedicated to delivering transformative therapies to patients
with orphan diseases and underserved conditions, announced that the
Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) has adopted a positive opinion
recommending marketing authorization for pediatric indication of
HyQvia (Human Normal Immunoglobulin (10%), Recombinant Human
Hyaluronidase), expanding on its use in adult patients.
The CHMP’s positive opinion will now be referred to the European
Commission (EC), which grants marketing authorization for medicines
in the European Union. Upon EC approval, HyQvia will be authorized
for pediatric use in all 28 EU member states plus Iceland and
Norway.
"We are pleased to receive a positive CHMP opinion for a
pediatric indication of HyQvia. This is a significant milestone in
increasing access to a treatment option for patients with
immunodeficiencies who can benefit from once-monthly dosing,” said
John Davis, M.D., M.P.H., vice president, Clinical Research and
Development and global therapeutic area head, Immunology, Baxalta.
“At Baxalta, we are committed to expanding the availability of
HyQvia to more patients through continued expansion in new
geographies and new therapeutic indications, with the goal of
reducing the burden for patients worldwide.”
Baxalta initially obtained marketing authorization in Europe in
May 2013 for the use of HyQvia as replacement therapy for adult
patients with primary and certain secondary immunodeficiencies.
Patients with immunodeficiencies are missing or have malfunctioning
components of their immune systems, placing them at greater risk
for recurring infections, longer recovery from illness and more
risk of potentially life-threatening complications.1
HyQvia was developed with a focus on addressing unmet treatment
needs for patients. The therapy offers a demonstrated safety and
efficacy profile while delivering a full dose of treatment in 1-2
infusion sites, up to once a month (every three to four weeks) for
many patients, and can be self-administered at home after
appropriate training. Since the first launch, HyQvia is now
available in 14 countries across Europe.
About HyQvia (Human Normal Immunoglobulin (10%), Recombinant
Human Hyaluronidase) in Europe
Indication and Usage
In Europe, today HyQvia is indicated as replacement therapy in
adults (>18 years) in primary immunodeficiency syndromes and in
myeloma or chronic lymphocytic leukaemia with severe secondary
hypogammaglobulinaemia and recurrent infections. For more
information on HyQvia in Europe, please visit
www.ema.europa.eu.
Important Risk Information
HyQvia must 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 must
not be used by patients with a systemic hypersensitivity to
hyaluronidase or recombinant human hyaluronidase. HyQvia must not
be used by patients with a hypersensitivity to any of the
excipients, including glycine.
HyQvia must not be given intravenously.
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 Primary Immunodeficiency
Primary immunodeficiencies (PI) are a group of more than 300
disorders in which part of the body's immune system is missing or
does not function properly. Normally, the immune system protects
the body from pathogenic microorganisms like bacteria, viruses, and
fungi, which can cause infectious diseases. When any part of a
person's immune system is absent or dysfunctional, they are
susceptible to infections and may take longer to recover from
infections. When a defect in the immune system is inherited, it is
called primary immune deficiency. It is estimated that as many as
six million children and adults may be affected by PI
worldwide.2
About Baxalta
Baxalta Incorporated (NYSE: BXLT) is a global biopharmaceutical
leader developing, manufacturing and commercializing therapies for
orphan diseases and underserved conditions in hematology,
immunology and oncology. Driven by passion to make a meaningful
impact on patients’ lives, Baxalta’s broad and diverse pipeline
includes biologics with novel mechanisms and advanced technology
platforms such as gene therapy. Launched in 2015 following
separation from Baxter International, Baxalta’s heritage in
biopharmaceuticals spans decades. Baxalta’s therapies are available
in more than 100 countries and it has advanced biological
manufacturing operations across 12 facilities, including
state-of-the-art recombinant production and plasma fractionation.
Headquartered in Northern Illinois, with its Global Innovation
Center in Cambridge, Mass., Baxalta employs 17,000 employees
worldwide.
Forward-Looking Statements
This release includes forward-looking statements concerning
HYQVIA, including expectations with regard to future regulatory
actions and potential impact on patients. Such statements are made
of the date that they were first issued and are based on current
expectations, beliefs and assumptions of management.
Forward-looking statements are subject to a number of risks and
uncertainties, many of which involve factors or circumstances that
are beyond Baxalta's control and which could cause actual results
to differ materially from those in the forward-looking statements,
including the following: clinical trial results; satisfaction of
regulatory and other requirements; actions of regulatory bodies and
other governmental authorities; changes in laws and regulations;
product quality, manufacturing or supply issues; patient safety
issues; and other risks identified in Baxalta's Annual Report on
Form 10-K and other Securities and Exchange Commission filings, all
of which are available on Baxalta's website. Baxalta expressly
disclaims any intent or obligation to update these forward-looking
statements except as required by law.
References
- IDF Patient & Family Handbook for
Primary Immunodeficiency Diseases. 5th edition. Blaese. 2013.
- Al-Herz, Waleed, et al. Primary
immunodeficiency diseases: an update on the classification from the
International Union of Immunological Societies Expert Committee for
Primary Immunodeficiency. Frontiers in Immunology 2014; V5:162:
1-33.
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version on businesswire.com: http://www.businesswire.com/news/home/20160502005296/en/
Baxalta Media RelationsKellie Hotz,
1-224-940-2202media@baxalta.comorBaxalta Investor
RelationsMary Kay Ladone,
+1-224-948-3371mary.kay.ladone@baxalta.comorLorna Williams,
+1-224-948-3511lorna.williams@baxalta.com
Baxalta Incorporated (NYSE:BXLT)
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