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百特药物ADVATE欧洲SmPC更新获EMA批准

来源:生物谷 2013-07-23 19:29

2013年7月23日讯 /生物谷BIOON/ --百特(Baxter)22日宣布,欧洲药品管理局(EMA)已批准了药物ADVATE(重组全长FVIII因子)的产品特性概要(SmPC)更新,纳入了IV期预防性研究的数据,使临床医师和患者能够更好地选择个性化的治疗方案。

现在,ADVATE在欧洲的SmPC药效学特性部分的更新内容包括了ADVATE IV期预防性研究的数据,该研究将标准的预防(prophylaxis)给药方案及药代动力学(PK)指导的预防给药方案与按需(on-demand)治疗方案进行了比较。PK指导的预防给药是基于每个患者个体对凝血因子的反应。在该项研究中,PK指导的给药方案为一些患者提供了每3天一个剂量的时间表选择。临床数据也表明,标准的预防给药方案及PK指导的预防给药方案在降低年出血率(ABR)方面具有同样的效果。

更重要的是,ADVATE SmPC为欧洲的临床医生和患者提供的已更新的药代动力学信息,能够更好地选择个性化的治疗方案。

ADVATE是一种全长重组FVIII产品,未添加任何血液添加剂,适用于A型血友病患者出血的治疗和预防,不适用于血管性血友病(von Willebrand disease,vWD)的治疗。目前该药已获全球59个国家批准。(生物谷Bioon.com)

英文原文:European Medicines Agency Approves SmPC Change to Baxter's ADVATE to Include Information on PK-Guided Dosing Study 

Personalized, PK-Guided Dosing Shown to be as Effective as Standard Prophylaxis in Reducing Annual Bleeding Rate for Hemophilia A Patients

LONDON, ENGLAND, JULY 22, 2013 - Baxter International Inc. (NYSE:BAX) today announced that the European Medicines Agency has authorized an update to the Summary of Product Characteristics (SmPC) for Baxter's ADVATE [Antihemophilic Factor (Recombinant) Plasma/Albumin Free Method, (in the EU, ADVATE, octocog alfa)] to include findings of the Phase IV prophylaxis study.

The pharmacodynamic properties section of the updated European SmPC now describes the findings of an ADVATE Phase IV prophylaxis study that compared standard and pharmacokinetic (PK)-guided prophylaxis dosing regimens to on-demand treatment with ADVATE. PK-guided prophylaxis is based on each individual's response to clotting factor. In the study (which supported the approval of the prophylactic dosing of ADVATE in the United States in 2011), of the two prophylactic regimens evaluated, the pharmacokinetic-driven regimen offered some patients the option of a dosing schedule of every three days. The clinical data demonstrated that PK-guided and standard prophylactic dosing regimens were comparably effective in reducing annual bleeding rates (ABR).1

"Importantly, this addition to our ADVATE SmPC offers clinicians and patients in Europe information about pharmacokinetics that may enable them to better personalize their treatment regimens with the goal of fewer infusions per year while still effectively reducing bleeds," said Anders Ullman, M.D., Ph.D., vice president of global research and development in Baxter's BioScience business.
In the prophylaxis study, an individualized pharmacokinetic guided dosing regimen (within a range of 20 to 80 IU of factor VIII per kg body weight at intervals of 72 ± 6 hours, n=23) was compared with a standard prophylactic dosing regimen (20 to 40 IU per kg every 48 ±6 hours, n=30) in previously-treated patients with Hemophilia A. The results showed a 98 percent reduction in annual bleed rate compared to the previous on-demand treatment period; 42 percent of patients experienced zero bleeds during one year on either of the prophylaxis regimens.

In Europe, for long-term prophylaxis against bleeding in patients with severe hemophilia A, the usual doses are 20 to 40 IU per kg body weight at intervals of two to three days. In patients under the age of six, doses of 20 to 50 IU of factor VIII per kg body weight three to four times weekly are recommended.

About ADVATE
ADVATE [Antihemophilic Factor (Recombinant) Plasma/Albumin Free Method, (in the EU, ADVATE, octocog alfa)] is indicated for the treatment and prophylaxis of bleeding in patients with hemophilia A (congenital factor VIII deficiency.) ADVATE is not indicated for the treatment of von Willebrand disease.

ADVATE is a full-length (derived from the complete FVIII gene) recombinant FVIII product that is processed without any blood-based additives. Because no blood derived components are added at any stage of the manufacturing process, the potential risk of transmitting pathogens that may be carried in blood-based additives is eliminated. There have been no confirmed reports of transmission of HIV, HBV or HCV with rFVIII therapies.

ADVATE is approved in 59 countries worldwide including the United States, Canada, 28 countries in the European Union, Argentina, Australia, Brazil, Chile, China, Colombia, Ecuador, Hong Kong, Iceland, Iraq, Japan, Kuwait, Macau, Malaysia, Mexico, New Zealand, Norway, Panama, Puerto Rico, Serbia, Singapore, South Korea, Suriname, Switzerland, Taiwan, Tunisia, Ukraine, Uruguay, and Venezuela.

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