新功能、新界面、新体验,扫描即可下载生物谷APP!
首页 » 白血病 » Celgene白血病新疗法获得欧洲批准

Celgene白血病新疗法获得欧洲批准

来源:生物谷 2013-08-10 20:12

2013年8月10日讯 /生物谷BIOON/ --Celgene公司研发的治疗白血病新疗法获得欧盟通过,这种疗法是将口服药物泊马度胺和类固醇地塞米松结合使用以达到治疗白血病的目的。欧盟作出这项决议是基于Celgene公司有455名志愿者参与的三期临床研究的研究数据上做出的。(生物谷Bioon.com)

详细英文报道:

Celgene ($CELG) has received the stamp of approval from the European Commission for its oral medication pomalidomide, in combination with the steroid dexamethasone, for the treatment of relapsed and refractory multiple myeloma in patients who have received previous therapies.

The approval adds to a growing numbers of meds that are being developed to combat the blood cancer, in which plasma cells--responsible for making antibodies that help fight infections--replicate uncontrollably and build up in the bone marrow.

The decision follows a positive opinion issued by Europe's Committee for Medicinal Products for Human Use (CHMP) in May. Approval was based on the results from a Phase III trial of 455 patients, in which patients treated with pomalidomide plus low-dose dexamethasone had prolonged survival.

Celgene, which markets Revlimid and other drugs for myeloma, said in a statement that it plans to launch the drug in the EU under the name Imnovid after submitting a regulatory notification to the European Medicines Agency to change the trade name. In February, the FDA approved the oral med, branded as Pomalyst in the U.S.

Last month, Celgene spent $100 million to gain an exclusive option to buy Acetylon Pharmaceuticals. It was a strategic move for Celgene, with Boston-based Acetylon's most advanced drug candidate in a Phase Ib clinical trial for multiple myeloma. Celgene is riding a wave of success lately, also reporting in July that sales were up 13% for the second quarter to $1.05 billion. Last quarter it reported 16.5% growth in sales of the breakthrough blood cancer drug and raised its earnings forecast for the year after beating analysts' projections.

European regulators have also approved Lonquex lipegfilgrastim from Teva Pharmaceutical Industries ($TEVA) to prevent chemotherapy-induced neutropenia, the condition of having a low count of certain white blood cells needed to guard against infections. Teva gained Lonquex through its 2010 acquisition of ratiopharm GmbH.

 

本网站所有注明“来源:生物谷”或“来源:bioon”的文字、图片和音视频资料,版权均属于生物谷网站所有。非经授权,任何媒体、网站或个人不得转载,否则将追究法律责任。取得书面授权转载时,须注明“来源:生物谷”。其它来源的文章系转载文章,本网所有转载文章系出于传递更多信息之目的,转载内容不代表本站立场。不希望被转载的媒体或个人可与我们联系,我们将立即进行删除处理。
温馨提示:87%用户都在生物谷APP上阅读,扫描立刻下载! 天天精彩!


相关标签

最新会议 培训班 期刊库