The US Food and Drug Administration has now issued full approval for Israeli drugmaker Teva’s Synribo (omacetaxine mepesuccinate) for chronic myeloid leukaemia (CML).
Synribo is indicated for adult patients with chronic phase (CP) or accelerated phase (AP) CML with resistance and/or intolerance to two or more tyrosine kinase inhibitors (TKIs).
Accelerated approval was handed out by the regulator back in October 2012 to accelerate patient access to the drug, and sufficient clinical trial data has now been gathered for full 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, president and Chief Executive, Global Specialty Medicines at Teva.
