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梯瓦抗癌药Synribo获FDA完全批准

来源:生物谷 2014-02-14 00:12

2014年2月13日讯 /生物谷BIOON/ --梯瓦(Teva)2月13日宣布,白血病药物Synribo(Omacetaxine Mepesuccinate)获得了FDA的完全批准(fully approval)。FDA曾于2012年10月授予Synribo加速批准(accelerated approval),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。在体外实验中,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。(生物谷bioon.com)

英文原文:Teva Announces Full FDA 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) 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.“

Indication

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

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

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