Teva's Synribo gets FDA approval

JERUSALEM — Teva Pharmaceutical Industries on Thursday announced that the Food and Drug Administration has granted full approval of Synribo (omacetaxine mepesuccinate) for injection.



The drug is indicated for adult patients with chronic phase or accelerated phase chronic myeloid leukemia with resistance and/or intolerance to two or more tyrosine kinase inhibitors.



“With this approval, based on the final analysis of two Phase-2 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.“