Synribo received provisional approval in 2012 subject to additional clinic trial data.
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) has announced that the US Food and Drug Administration (FDA) has granted full approval of Synribo (omacetaxine mepesuccinate) for injection. Teva's oncology portfolio product initially received an accelerated approval in October 2012. But the FDA requested additional clinical trial data to fulfill post marketing requirements.
Synribo is indicated for adult patients with chronic phase or accelerated phase myeloid leukemia (CML) with resistance and/or intolerance to two or more tyrosine kinase inhibitors (TKIs).
Teva president and CEO global specialty medicines Rob Koremans 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."
Published by Globes [online], Israel business news - www.globes-online.com - on February 13, 2014
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