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|February 13, 2014 8:30 a.m.|
|Teva Announces Full FDA Approval of SYNRIBO® (Omacetaxine Mepesuccinate) for Injection|
24-Month FDA Post Marketing Commitment Completed
SYNRIBO is indicated for adult patients with chronic phase (CP) or accelerated phase (AP) chronic myeloid leukemia (CML) with resistance and/or intolerance to two or more tyrosine kinase inhibitors (TKIs).
“With this approval, based on the final analysis of two Phase II trials that evaluated efficacy and tolerability data of SYNRIBO®, we believe healthcare providers can be even more confident in the clinical profile of this important medicine,” said Rob Koremans, M.D., President and CEO, Global Specialty Medicines. “This approval reinforces our ongoing commitment to providing SYNRIBO® to people living with CML who have failed two or more TKI therapies.“
SYNRIBO® is indicated for the treatment of adult patients with chronic or accelerated phase chronic myeloid leukemia (CML) with resistance and/or intolerance to two or more tyrosine kinase inhibitors (TKI).
Important Safety Information
Warnings and Precautions
Chronic myeloid leukemia (also called chronic myelogenous leukemia) is
one of four main types of leukemia and is a cancer of the blood and bone
marrow. In CML, part of the DNA from chromosome 9 breaks off and trades
places with chromosome 22 during cell division. This results in the
“Philadelphia chromosome,” which is an abnormal chromosome 22 that
contains the BCR-ABL hybrid gene. This hybrid gene leads to
over-production of the enzyme tyrosine kinase in the bone marrow, which
causes too many stem cells to develop into white blood cells
(granulocytes or blasts).
SYNRIBO®, which was originally granted an accelerated
approval by the
For Full Prescribing Information, click here.
About the Phase 2 Pivotal Studies (202 and 203)
The original approval of SYNRIBO® was based on an analysis of combined data subsets from two Phase 2, open-label, multicenter studies. The pooled analysis included patients who had received 2 or more approved TKIs and, at a minimum, had evidence of resistance or intolerance to dasatinib and/or nilotinib. 47% of CP patients and 63% of AP patients had failed treatment with imatinib, dasatinib, and nilotinib. The majority of patients had also received other treatments including hydroxyurea, interferon, and cytarabine.
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from potential purported generic equivalents); the possibility of
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development efforts invested in our pipeline of specialty and other
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during the timeframe intended by our cost reduction program; our ability
to identify and successfully bid for suitable acquisition targets or
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the extent to which any manufacturing or quality control problems damage
our reputation for quality production and require costly remediation;
our potential exposure to product liability claims that are not covered
by insurance; increased government scrutiny in both the U.S. and
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