2014年10月21日发布

梯瓦（Teva）2月13日宣布，白血病药物Synribo（OmacetaxineMepesuccinate）获得了FDA的完全批准（fullyapproval）。FDA曾于2012年10月授予Synribo加速批准（acceleratedapproval），用于对2种及以上酪氨酸激酶抑制剂（TKIs）有抗性或不耐受的慢性期（CP）或加速期（AP）慢性髓性白血病（CML）成人患者的治疗。该药是首个用于CML治疗的蛋白质合成抑制剂。

Synribo的作用机制尚未完全阐明，但包括抑制蛋白质合成。在体外试验中，Synribo直接独立地与Bcr-AbI结合，能够降低Bcr-AbI癌蛋白和McI-1的蛋白水平。此外，Synribo在野生型及T315I突变的Bcr-AbI CML小鼠模型中也有作用。

与Synribo相关的严重不良反应包括骨髓移植、出血、高血糖，其中骨髓移植及脑出血是致命性的。此外，女性患者在接受Synribo时，应避免妊娠。

英文原文：Teva Announces FullFDA Approval of SYNRIBO® (Omacetaxine Mepesuccinate) for Injection

24-Month FDA Post Marketing Commitment Completed

JERUSALEM--(BUSINESS WIRE)--Feb. 13, 2014-- 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) forinjection. This oncology portfolio product received an accelerated approval inOctober, 2012 with additional clinical trial data required to fulfill postmarketing requirements set forth by the FDA.

SYNRIBO is indicated for adult patients withchronic 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 oftwo Phase II trials that evaluated efficacy and tolerability data of SYNRIBO®,we believe healthcare providers can be even more confident in the clinicalprofile of this important medicine,” said Rob Koremans, M.D., President andCEO, Global Specialty Medicines. “This approval reinforces our ongoingcommitment to providing SYNRIBO® to people living with CML who have failed twoor more TKI therapies.“

Indication

SYNRIBO® is indicated for the treatment of adultpatients with chronic or accelerated phase chronic myeloid leukemia (CML) withresistance and/or intolerance to two or more tyrosine kinase inhibitors (TKI).

About SYNRIBO®

SYNRIBO®, which was originally granted an accelerated approval by the FDA inOctober 2012, is the first protein synthesis inhibitor for CML. While adetailed understanding of how SYNRIBO® works has not been fully defined, it hasbeen shown to prevent the production of specific proteins. The proteins affectedby SYNRIBO® are known as Bcr-Abl and Mcl-1, as shown in laboratory studies notinvolving patients. These are examples of some of the proteins that areproduced in higher levels by cancerous CML cells and help drive the disease. Asa protein synthesis inhibitor, the way SYNRIBO® is believed to work does notdirectly depend on Bcr-Abl binding.

ple patient populations.