新功能、新界面、新体验,扫描即可下载生物谷APP!
首页 » 自身免疫性疾病 » FDA委员会建议批准百特免疫缺陷药物HyQiva

FDA委员会建议批准百特免疫缺陷药物HyQiva

来源:生物谷 2014-08-03 13:28

2014年8月3日讯 /生物谷BIOON/ --百特国际(Baxter International)和Halozyme制药7月31日联合宣布,FDA血液制品顾问委员会(BPAC)以15比1的投票结果,认为HyQvia用于治疗原发性免疫缺陷症(PI)具有良好的风险/效益属性,建议批准HyQvia用于原发性免疫缺陷症(PI)的治疗。FDA预计将于2014年第三季度作出审查决定。

HyQvia由人正常免疫球蛋白(IGSC,10%)和重组人透明质酸酶(hyaluronidase)组成,透明质酸酶有利于IGSC的分散和吸收,从而提高其生物利用度。

FDA曾于2012年因安全性问题拒绝批准HyQiva。之后,百特和Halozyme应FDA的要求,提交了额外的临床前数据,并于2013年12月提交了有关HyQvia的一份修订版生物制品许可申请(BLA),以便重新启动关于HyQvia用于原发性免疫缺陷(PI)成人患者治疗的审查程序。

原有BLA的提交,基于一项前瞻性、开放标签、非对照、多中心III期临床试验的数据。该项研究评估了HyQvia用于预防急性严重细菌感染的安全性和有效性,同时与静脉给药型免疫球蛋白的药代动力学参数进行了比较。该项研究的目的是在单一的皮下注射位点注入一剂3或4周剂量的HyQvia。该项研究中,急性严重细菌感染率为0.025/人/年,低于所要求的疗效阈值1.0/人/年。对HyQvia的耐受性评估数据表明,最常见的不良反应为输注部位反应、头痛、疲劳、发热。

HyQvia已于2013年5月获欧盟批准,作为一种替代疗法,用于原发性免疫缺陷综合征(primary immunodeficiency syndromes)及伴有继发性低丙种球蛋白血症和反复感染的骨髓瘤或慢性淋巴细胞白血病成人患者(≥18岁)的治疗。(生物谷Bioon.com)

英文原文:FDA Advisory Committee Panel Provides Favorable Recommendation on Baxter's HyQvia for Primary Immunodeficiency 

DEERFIELD, Ill. and SAN DIEGO, Calif., July 31, 2014 - Baxter International Inc. (NYSE:BAX) and Halozyme Therapeutics, Inc., (NASDAQ:HALO) today announced that the Blood Products Advisory Committee (BPAC) of the U.S. Food and Drug Administration (FDA) voted 15-1 that HyQvia [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase], Baxter's investigational subcutaneous treatment for patients with primary immunodeficiency (PI), has a favorable risk/benefit profile.

HyQvia was approved in Europe in 2013 for adults (≥18 years) with primary immunodeficiency syndromes and myeloma or chronic lymphocytic leukaemia (CLL) with severe secondary hypogammaglobulinaemia and recurrent infections.

Data presented at today's advisory committee meeting included a review of the preclinical and clinical data supporting the HyQvia application. The FDA will consider the recommendation from the BPAC in its review of Baxter's amendment to the Biologics License Application (BLA) submitted in December 2013. The company expects the FDA response in the third quarter.

"We are hopeful that the positive support for HyQvia is the next step toward providing a new treatment option for patients with primary immunodeficiency in the United States. We look forward to working closely with the FDA as it completes its review," said Ludwig Hantson, Ph.D., president of Baxter BioScience.

"Today's BPAC vote underscores the strength of the HyQvia data and our rHuPH20 platform," commented Dr. Helen Torley, President and Chief Executive Officer of Halozyme. "Our rHuPH20 platform has been studied in thousands of patients spanning multiple disease states and a number of approved products."

HyQvia was approved by the European Commission for EU member states in 2013 and is currently being prescribed in several European countries, including Germany, Netherlands, Sweden, Norway, Denmark, Ireland and Italy.

About HyQvia
HyQvia is a product consisting of human normal immunoglobulin (IG 10%) and recombinant human hyaluronidase (licensed from Halozyme Therapeutics). The IG provides the therapeutic effect and the recombinant human hyaluronidase facilitates the dispersion and absorption of the IG administered subcutaneously, increasing its bioavailability. The IG is a 10% solution that is prepared from human plasma consisting of at least 98% IgG, which contains a broad spectrum of antibodies.

HyQvia is indicated in Europe as replacement therapy in adults (≥18 years) with primary immunodeficiency syndromes and in myeloma or chronic lymphocytic leukaemia (CLL) with severe secondary hypogammaglobulinaemia and recurrent infections.

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