Teva Pharmaceutical Industries has received the US Food and Drug Administration (FDA) approval of Synribo (omacetaxine mepesuccinate) for injection. This oncology portfolio product received an accelerated approval in October, 2012 with additional clinical trial data required to fulfill post marketing requirements set forth by the FDA.

Synribo is indicated for adult patients with chronic phase (CP) or accelerated phase (AP) chronic myeloid leukaemia (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, MD, 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, which was originally granted an accelerated approval by the FDA in October 2012, is the first protein synthesis inhibitor for CML. While a detailed understanding of how Synribo works has not been fully defined, it has been shown to prevent the production of specific proteins. The proteins affected by Synribo are known as Bcr-Abl and Mcl-1, as shown in laboratory studies not involving patients. These are examples of some of the proteins that are produced in higher levels by cancerous CML cells and help drive the disease. As a protein synthesis inhibitor, the way Synribo is believed to work does not directly depend on Bcr-Abl binding.

Teva Pharmaceutical Industries Ltd. 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.