BANNOCKBURN, Ill., Nov. 30, 2015 /PRNewswire/ -- Baxalta
Incorporated (NYSE: BXLT), a global biopharmaceutical leader
dedicated to delivering transformative therapies to patients with
orphan diseases and underserved medical conditions, today announced
the launch and first shipments of ADYNOVATE [Antihemophilic Factor
(Recombinant), PEGylated], an extended circulating half-life
recombinant factor VIII (rFVIII) treatment for hemophilia A based
on full-length ADVATE [Antihemophilic Factor (Recombinant)]. The
treatment was approved by the U.S. Food and Drug Administration
(FDA) in November.
"Patients living with hemophilia are increasingly looking for
and need treatment options that can address their individual
needs," said Dr. Michael Tarantino,
medical director of the Bleeding & Clotting Disorders
Institute. "The simplicity of ADYNOVATE's twice weekly dosing
schedule offers an important new option for the hemophilia
community, delivering first and foremost on what matters most -
bleed protection, while also easing the schedule of their
prophylactic treatment."
With ADYNOVATE, Baxalta expands its industry-leading hemophilia
portfolio and further widens the variety of treatment options to
meet individual patient needs at each treatment stage. The company
continues to invest in ADYNOVATE to expand the product's value for
more hemophilia patients worldwide. As the company prepares for
additional global introductions of ADYNOVATE, the treatment has
been submitted for regulatory approval in Japan. Following completion of the pediatric
study in early 2016, Baxalta expects to file for marketing
authorization in Europe.
"We are excited to be able to introduce ADYNOVATE to patients in
the United States just weeks after
receiving FDA approval, marking the first of many planned product
launches in our broad pipeline," said Brian
Goff, executive vice president and president, Hematology.
"Looking ahead, we're continuing to build the value of ADYNOVATE
with additional studies for new indications, and plan to deliver
this innovative treatment to more patients around the world as we
continue to pursue our vision of a Bleed-Free World."
ADYNOVATE was developed through a collaboration with Nektar
Therapeutics (NASDAQ: NKTR). For more information on ADYNOVATE,
please visit www.adynovate.com or www.adynovatepro.com. Additional
resources are available at www.hematologysupport.com.
About ADYNOVATE
ADYNOVATE, Antihemophilic Factor (Recombinant), PEGylated, is a
human antihemophilic factor indicated in adolescent and adult
patients (12 years and older) with hemophilia A (congenital factor
VIII deficiency) for:
- On-demand treatment and control of bleeding episodes
- Routine prophylaxis to reduce the frequency of bleeding
episodes
ADYNOVATE is not indicated for the treatment of von Willebrand
disease.
Detailed Important Risk Information for ADYNOVATE
CONTRAINDICATIONS
ADYNOVATE is contraindicated in patients who have had prior
anaphylactic reaction to ADYNOVATE, to the parent molecule
(ADVATE), mouse or hamster protein, or excipients of ADYNOVATE
(e.g. Tris, mannitol, trehalose, glutathione, and/or polysorbate
80).
WARNINGS & PRECAUTIONS
Hypersensitivity
Reactions
Hypersensitivity reactions are possible with ADYNOVATE.
Allergic-type hypersensitivity reactions, including anaphylaxis,
have been reported with other recombinant antihemophilic factor
VIII products, including the parent molecule, ADVATE. Early signs
of hypersensitivity reactions that can progress to anaphylaxis may
include angioedema, chest tightness, dyspnea, wheezing, urticaria,
and pruritus. Immediately discontinue administration and initiate
appropriate treatment if hypersensitivity reactions occur.
Neutralizing Antibodies
Formation of neutralizing antibodies (inhibitors) to factor VIII
can occur following administration of ADYNOVATE. Monitor patients
regularly for the development of factor VIII inhibitors by
appropriate clinical observations and laboratory tests. Perform an
assay that measures factor VIII inhibitor concentration if the
plasma factor VIII level fails to increase as expected, or if
bleeding is not controlled with expected dose.
ADVERSE REACTIONS
Common adverse reactions (>1% of subjects) reported in the
clinical studies were headache and nausea.
For Full Prescribing Information, visit
http://baxalta.com/assets/documents/ADYNOVATE_PI.pdf.
About ADVATE
ADVATE [Antihemophilic Factor (Recombinant)] is a recombinant
antihemophilic factor indicated for use in children and adults with
hemophilia A (congenital factor VIII deficiency) for:
- Control and prevention of bleeding episodes
- Perioperative management
- Routine prophylaxis to prevent or reduce the frequency of
bleeding episodes
ADVATE is not indicated for the treatment of von Willebrand
disease.
Detailed Important Risk Information for ADVATE
CONTRAINDICATIONS
ADVATE is contraindicated in
patients who have life-threatening hypersensitivity reactions,
including anaphylaxis, to mouse or hamster protein or other
constituents of the product.
WARNINGS & PRECAUTIONS
Hypersensitivity
Reactions
Allergic-type hypersensitivity reactions,
including anaphylaxis, have been reported with ADVATE. Symptoms
include dizziness, paresthesia, rash, flushing, facial swelling,
urticaria, dyspnea, pruritus, and vomiting.
Discontinue ADVATE if hypersensitivity symptoms occur and
administer appropriate emergency treatment.
Neutralizing Antibodies
Neutralizing antibodies
(inhibitors) have been reported following administration of ADVATE
predominantly in previously untreated patients (PUPs) and
previously minimally treated patients (MTPs). Monitor all patients
for the development of factor VIII inhibitors by appropriate
clinical observation and laboratory testing. If expected plasma
factor VIII activity levels are not attained, or if bleeding is not
controlled with an expected dose, perform an assay that measures
factor VIII inhibitor concentration.
ADVERSE REACTIONS
Serious adverse reactions seen with ADVATE are hypersensitivity
reactions, including anaphylaxis, and the development of high-titer
inhibitors necessitating alternative treatments to factor VIII.
The most common adverse reactions observed in clinical trials
(frequency ≥5% of subjects) were pyrexia, headache, cough,
nasopharyngitis, arthralgia, vomiting, upper respiratory tract
infection, limb injury, nasal congestion, and diarrhea.
Please see full prescribing information for ADVATE at:
www.advate.com /assets/pdf/advate_iri_pi.pdf.
ADVATE has a demonstrated efficacy and safety profile for the
treatment of hemophilia A. ADVATE is a full-length (derived from
the complete FVIII gene) recombinant FVIII product that is
processed without any blood-based additives. Because no
blood-derived components are added at any stage of the
manufacturing process, the potential risk of transmitting pathogens
that may be carried in bloodbased additives is virtually
eliminated. There have been no confirmed reports of transmission of
HIV, HBV or HCV with rFVIII treatments.
ADVATE is the world's most prescribed FVIII treatment. It is
currently approved in 67 countries worldwide, including
the United States, Canada, 28 countries in the European Union,
Algeria, Argentina, Australia, Brazil, Brunei, Chile, China,
Colombia, Ecuador, Hong
Kong, Iceland, India, Iraq,
Israel, Japan, Kuwait, Macau, Malaysia, Mexico, Morocco, New
Zealand, Norway,
Panama, Puerto Rico, Qatar, Russia, Saudi
Arabia, Serbia, Singapore,
South Korea, Suriname,
Switzerland, Taiwan, Tunisia, Turkey, Ukraine, Uruguay, and Venezuela.
About Baxalta
Baxalta Incorporated (NYSE: BXLT) is a $6
billion global biopharmaceutical leader developing,
manufacturing and commercializing therapies for orphan diseases and
underserved conditions in hematology, oncology and immunology.
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.
The Baxalta Global Innovation and R&D Center is located in
Cambridge, Massachusetts. 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, Baxalta employs 16,000
employees worldwide.
Forward-Looking Statements
This release includes forward-looking statements concerning
ADYNOVATE, including expectations with regard to clinical trials,
regulatory actions, commercial launch plans and the 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 filings with the Securities and
Exchange Commission, 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.
Baxalta, Advate and Adynovate are trademarks of Baxalta
Incorporated
Baxalta Media Relations
Kellie Hotz, +1-224-940-2202,
media@baxalta.com
Baxalta Investor Relations
Mary Kay Ladone, +1-224-948-3371,
mary.kay.ladone@baxalta.com
Lorna Williams, +1-224-948-3511,
lorna.williams@baxalta.com
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SOURCE Nektar Therapeutics