Teva Wins FDA Approval For Synribo Injection
Teva announced it has received full approval from the U.S. Food and Drug Administration (FDA) for its leukemia treatment SYNRIBO (omacetaxine mepesuccinate) for injection. Teva President and CEO, Global Specialty Medicines Rob Koremans, M.D., said, “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. 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 in the treatment of adult patients with chronic phase (CP) or accelerated phase (AP) chronic myeloid leukemia (CML) who are either intolerant or resistant to two or more tyrosine kinase inhibitors (TKIs). It is the first protein synthesis inhibitor for CML. How Synribo works is yet to be fully understood, but observations show that it prevents the production of certain proteins (Bcr-Abl and Mcl-1) in the body produced in higher levels by cancerous CML cells. Both proteins help to drive the disease. Though Synribo is a protein synthesis inhibitor, it is believed that the drug does not directly depend on Bcr-Abl binding.
CML affects the blood and bone marrow. In CML, the “Philadelphia chromosome” containing the hybrid gene Bcr-Abl is present. The hybrid gene drives the overproduction of the enzyme tyrosine kinase in the bone marrow. This leads to too many stem cells developing into white blood cells. According to the American Cancer Society, 5,980 new cases of CML will be diagnosed in the US in 2014 with 810 CML-related deaths. Research shows the prevalence of CML has grown significantly since 2001 following the introduction of new treatments.
Synribo originally received approval in October 2012 with additional clinical trial data needed to meet post marketing requirements set by the FDA.