New Administration Option Will Offer Patients More Treatment
Flexibility
JERUSALEM--(BUSINESS WIRE)--Dec. 23, 2014--
Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) today announced that the
U.S. Food and Drug Administration (FDA) has approved GRANIX®
(tbo-filgrastim) Injection for self-administration by patients and
caregivers. With the approval of this additional administration option,
physicians will soon have the flexibility to prescribe GRANIX for either
in-office or at home use.
GRANIX, a leukocyte growth factor, is indicated for reduction in the
duration of severe neutropenia in patients with nonmyeloid malignancies
receiving myelosuppressive anticancer drugs associated with a clinically
significant incidence of febrile neutropenia. GRANIX has been
commercially available in the U.S. since November 2013. The currently
marketed GRANIX syringe is indicated only for administration by a
healthcare professional. Teva plans to launch a new GRANIX syringe, for
self-administration by patients and caregivers, in early 2015.
“In partnership with their physician, patients will be able to decide
whether administering GRANIX via self-injection at home or by a
healthcare professional is the right course for them,” said Lee S.
Schwartzberg, MD, FACP, Division Chief of Hematology Oncology at the
University of Tennessee Health Science Center. “Selecting a course of
self-administration may allow patients to consolidate the number of
required visits to their physician and allow additional access for
patients who have challenges in visiting their providers.”
“This new administration option demonstrates Teva’s continued commitment
to enhancing the patient experience by providing patients, in
partnership with their physician, with flexibility in their treatment
regimen,” said Paul Rittman, Vice President and General Manager, Teva
Oncology. “We are proud to be adding to the value of this important
product.”
About Granix®
GRANIX® is a leukocyte growth factor indicated for reduction
in the duration of severe neutropenia in patients with non-myeloid
malignancies receiving myelosuppressive anticancer drugs associated with
a clinically significant incidence of febrile neutropenia. The safety of
GRANIX was evaluated in three Phase 3 clinical trials in patients
receiving myelosuppressive chemotherapy for breast cancer, lung cancer,
and non-Hodgkin lymphoma (NHL). The most common treatment-emergent
adverse reaction (at least 1% or greater and two times more frequent
than in the placebo group) that occurred in patients treated with GRANIX
was bone pain. In a Phase 3 clinical study, GRANIX demonstrated a 71
percent reduction in the duration of severe neutropenia when compared to
placebo. GRANIX significantly reduced the duration of severe neutropenia
when compared to placebo (1.1 days vs. 3.8 days). The efficacy of GRANIX
was evaluated in a multinational, multicenter, randomized, controlled
Phase 3 study of chemotherapy-naïve patients with high-risk stage II,
stage III, or stage IV breast cancer receiving a myelosuppressive
regimen of doxorubicin (60 mg/m2 IV bolus) and docetaxel (75
mg/m2). Comparisons with placebo occurred in the first cycle.
Important Safety Information
-
Splenic rupture: Splenic rupture, including fatal cases, can
occur following the administration of human granulocyte
colony-stimulating factors (hG-CSFs). Discontinue GRANIX and evaluate
for an enlarged spleen or splenic rupture in patients who report upper
abdominal or shoulder pain after receiving GRANIX.
-
Acute respiratory distress syndrome (ARDS): ARDS can occur in
patients receiving hG-CSFs. Evaluate patients who develop fever and
lung infiltrates or respiratory distress after receiving GRANIX, for
ARDS. Discontinue GRANIX in patients with ARDS.
-
Allergic reactions: Serious allergic reactions, including
anaphylaxis, can occur in patients receiving hG-CSFs. Reactions can
occur on initial exposure. Permanently discontinue GRANIX in patients
with serious allergic reactions. Do not administer GRANIX to patients
with a history of serious allergic reactions to filgrastim or
pegfilgrastim.
-
Use in patients with sickle cell disease: Severe and sometimes
fatal sickle cell crises can occur in patients with sickle cell
disease receiving hG-CSFs. Consider the potential risks and benefits
prior to the administration of GRANIX in patients with sickle cell
disease. Discontinue GRANIX in patients undergoing a sickle cell
crisis.
-
Capillary leak syndrome (CLS): CLS can occur in patients
receiving hG-CSFs and is characterized by hypotension,
hypoalbuminemia, edema and hemoconcentration. Episodes vary in
frequency, severity and may be life-threatening if treatment is
delayed. Patients who develop symptoms of CLS should be closely
monitored and receive standard symptomatic treatment, which may
include a need for intensive care.
-
Potential for tumor growth stimulatory effects on malignant cells: The
granulocyte colony-stimulating factor (G-CSF) receptor, through which
GRANIX acts, has been found on tumor cell lines. The possibility that
GRANIX acts as a growth factor for any tumor type, including myeloid
malignancies and myelodysplasia, diseases for which GRANIX is not
approved, cannot be excluded.
-
Most common treatment-emergent adverse reaction: The most
common treatment-emergent adverse reaction that occurred in patients
treated with GRANIX at the recommended dose with an incidence of at
least 1% or greater and two times more frequent than in the placebo
group was bone pain.
For GRANIX Full Prescribing Information, please visit: http://granixrx.com/pdf/prescribing-information.pdf
About Neutropenia
Neutropenia is a hematological disorder characterized by an abnormally
low number of neutrophils. A person with severe neutropenia has an
absolute neutrophil count that is less than 500 mm2 and has a
high risk of infection. Neutrophils usually make up 40-60 percent of
circulating white blood cells and serve as the primary defense against
infections by destroying bacteria in the blood. When chemotherapy agents
attack cancer cells in the body, neutrophils and other cells are also
attacked. This results in a decrease in healthy white blood cells,
making it harder for the body to fight infections. Patients receiving
chemotherapy are at risk of becoming neutropenic and can become
susceptible to infections that may become life-threatening.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) is a leading global
pharmaceutical company, committed to increasing access to high-quality
healthcare by developing, producing and marketing affordable generic
drugs as well as innovative and specialty pharmaceuticals and active
pharmaceutical ingredients. Headquartered in Israel, Teva is the world's
leading generic drug maker, with a global product portfolio of more than
1,000 molecules and a direct presence in approximately 60 countries.
Teva's Specialty Medicines businesses focus on CNS, respiratory,
oncology, pain, and women's health therapeutic areas as well as
biologics. Teva currently employs approximately 45,000 people around the
world and reached $20.3 billion in net revenues in 2013.
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Source: Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd.
IR:
United States
Kevin
C. Mannix, (215) 591-8912
or
Ran Meir, (215)
591-3033
or
Israel
Tomer Amitai, 972 (3) 926-7656
or
PR:
Israel
Iris
Beck Codner, 972 (3) 926-7687
or
United States
Denise
Bradley, (215) 591-8974
or
Nancy Leone, (215)
284-0213