打开APP

百健艾迪长效凝血因子Alprolix III期B-LONG研究取得积极数据

  1. Alprolix
  2. 凝血因子IX
  3. 百健艾迪
  4. 血友病

来源:生物谷 2013-07-04 09:55

2013年7月3日讯 /生物谷BIOON/ --7月2日,百健艾迪(Biogen Idec)和合作伙伴瑞典制药公司Swedish Orphan Biovitrum(SOBI)公布了有关长效重组因子IX候选药物Alprolix III期B-LONG研究数据。

2013年7月3日讯 /生物谷BIOON/ --7月2日,百健艾迪(Biogen Idec)和合作伙伴瑞典制药公司Swedish Orphan Biovitrum(SOBI)公布了有关长效重组因子IX候选药物Alprolix III期B-LONG研究数据。

新数据进一步加强了Alprolix的潜在安全性、疗效、药代动力学属性,同时突显了Alprolix在所有类型患者中研究数据的一致性,以及临床医师对于Alprolix在重大手术术中及术后治疗急性出血及出血控制中有效性方面有利评级的一致性。

Alprolix是新一类长效凝血因子疗法中的首个候选药物,新数据支持了Alprolix在减少B型血友病患者预防性输注次数方面的潜力。

出血治疗(Treatment of Bleeding):III期B-LONG研究,在预防性(prophylaxis)治疗组和按需(on-demand)治疗组中评价了Alprolix对急性出血事件的治疗。数据表明,单次注射Alprolix可控制超过90%的出血事件,2次或更少次注射可控制超过97%的出血事件。

手术分析(Surgery Analysis):III期B-LONG研究数据分析结果表明,Alprolix在12例B型血有病患者14次重大手术术中和术后出血控制中具有一致性。医师评级结果显示,Alprolix在术中止血方面,13/14例手术评级为“优秀(excellent)”,1/14例评级为“好(good)”。

目前,Alprolix用于治疗B型血有病的生物制品许可申请(BLA)正在接受FDA的审查。同时,百健艾迪也已向加拿大和澳大利亚的监管机构提交了Alprolix治疗B型血有病的上市许可申请(MA)。

Alprolix是利用百健艾迪新颖及专有的单体Fc融合技术开发的一种凝血因子,该技术利用了一种自然发生的途径来延迟凝血因子的降解并使其重新进入血液循环,从而导致更长的循环半衰期。

Fc融合技术已被用于7种获FDA批准用于慢性疾病的产品,包括类风湿性关节炎、牛皮癣、血小板疾病等。百健艾迪是首个也是唯一一个将该专有技术应用于血友病的公司。(生物谷Bioon.com)

英文原文:BIOGEN IDEC AND SOBI PRESENT NEW DATA FROM THE PHASE 3 STUDY OF THEIR LONG-LASTING HEMOPHILIA FACTOR CANDIDATE ALPROLIX?

Additional B-LONG Study Results Support Positive Clinical Profile of ALPROLIX for Hemophilia B

WESTON, Mass. and STOCKHOLM--(BUSINESS WIRE)--Jul. 2, 2013-- Biogen Idec (NASDAQ: BIIB) and Swedish Orphan Biovitrum AB (publ) (Sobi) (STO: SOBI) today presented new findings for their long-lasting recombinant factor IX candidate ALPROLIX* for hemophilia B at the XXIV International Society on Thrombosis and Haemostasis (ISTH) Congress in Amsterdam, The Netherlands. Three oral presentations showcase new data that reinforce the potential safety, efficacy and pharmacokinetic profile of ALPROLIX. The data highlight the consistency of results with ALPROLIX across patient types and favorable physician ratings of its efficacy in treating acute bleeding episodes and controlling bleeding during and after major surgery.

“ALPROLIX is the first product candidate in a new class of long-lasting clotting factor therapies, and the data presented today support the potential of the therapy to reduce the frequency of prophylactic infusions for patients with hemophilia B,” said Glenn Pierce, M.D., Ph.D., senior vice president of Global Medical Affairs and chief medical officer of Biogen Idec’s hemophilia therapeutic area. “These new data help to build the clinical profile of ALPROLIX by increasing our understanding of its efficacy.”

Treatment of Bleeding

An evaluation of the treatment of acute bleeding episodes across the prophylaxis and episodic (on-demand) treatment arms of the phase 3 B-LONG study showed that more than 90% of bleeds were controlled with a single injection of ALPROLIX and more than 97% were controlled with two or fewer injections. These data were showcased in the e-poster presentation:

Treatment of Bleeding Episodes in Subjects with Haemophilia B with the Long-Lasting Recombinant Factor IX Fc Fusion Protein (rFIXFc) in the Phase 3 B-LONG Study

Surgery Analysis

Results from an analysis of the phase 3 B-LONG study showed that ALPROLIX consistently controlled bleeding during and after 14 major surgeries in 12 patients with hemophilia B. Physicians reported high efficacy levels of ALPROLIX during surgery, with hemostasis (the stoppage of bleeding) rated as “excellent” for 13/14 surgeries and “good” for 1/14 surgeries. According to investigator analyses, the results were comparable to that for similar surgeries in people without hemophilia. These data were showcased in the e-poster presentation:

Long-Lasting Recombinant Factor IX Fc Fusion (rFIXFc) for Perioperative Management of Subjects with Haemophilia B in the Phase 3 B-LONG Study

Population Pharmacokinetics (PK) Analysis

Analysis of a population pharmacokinetics (popPK) model developed for ALPROLIX demonstrated that the model accurately predicts peak and trough factor IX activity levels achieved in the B-LONG clinical study at a variety of ALPROLIX doses. These data were showcased in the e-poster presentation:

Clinical Implications of Population Pharmacokinetics of rFIXFc in Routine Prophylaxis, Control of Bleeding and Perioperative Management for Haemophilia B Patients

“These new data from the B-LONG study support the potential application of Fc fusion technology in hemophilia,” said Birgitte Volck, M.D., Ph.D., senior vice president development and chief medical officer of Sobi. “The results add to the growing body of evidence supporting the potential efficacy and safety of this long-lasting clotting factor candidate for the treatment of hemophilia B.”

ALPROLIX Global Regulatory Status

A Biologics License Application (BLA) for Biogen Idec’s long-lasting hemophilia product candidate ALPROLIX is currently under review with the U.S. Food and Drug Administration (FDA) for the treatment of hemophilia B.

Marketing Applications for ALPROLIX have been submitted in Canada and Australia for the treatment of hemophilia B. Additional regulatory filings are planned.

About the Fc Fusion Technology Platform

ALPROLIX is a clotting factor under development using Biogen Idec’s novel and proprietary monomeric Fc fusion technology, which makes use of a naturally occurring pathway that delays the breakdown of factor in the body and cycles it back into the bloodstream, resulting in a longer circulating half-life. Fc fusion technology is used in seven FDA-approved products for the treatment of chronic diseases including rheumatoid arthritis, psoriasis and platelet disorders. Biogen Idec is the first and only to apply this proprietary technology to hemophilia.

版权声明 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。

87%用户都在用生物谷APP 随时阅读、评论、分享交流 请扫描二维码下载->