Synribo received provisional approval in 2012 subject to additional clinic trial data.
Teva Pharmaceutical Industries
Ltd. (NYSE: TEVA) today announced that the U.S. Food and Drug Administration (FDA) has granted full 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 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.“