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Simoctocog alfa for the treatment of hemophilia A

机译：Simoctocog Alfa治疗血友病A.

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Introduction: Hemophilia A is the most frequent inherited bleeding disorder and most challenging coagulation disorder. To combat this, a number of new improved rFVIII/IX concentrates have recently been approved. Some of them are derived from protein fusion biotechnology or pegylation to extend their half-life (HL). However, prophylaxis has become a standard of care to prevent arthropathy in hemophiliacs though the need of frequent venipunctures is a major obstacle to primary prophylaxis. The new Extended Half-Life (EHL) rFIX concentrates allow increased intervals, while the improved HL of new rFVIII was moderate. rFVIII Simoctocog alfa is produced in Human Embryonic Kidney (HEK) cells and the post-translational modifications performed by HEK cells are very similar to those occurring in the native FVIII.Areas covered: Herein, the author provides a review of simoctocog alfa with its contents including information on simoctocog alfa's manufacturing, clinical trials, safety and tolerability. They also give their expert opinion and future perspectives on this therapy.Expert opinion: An important advantage of simoctocog alfa is the possibility to omit at least 30% of venipunctures with prophylaxis. Consequently, the standard three times weekly bolus administrations may be reduced to twice weekly, meaning approximately 50 fewer venipunctures per year. This may be particularly helpful to children.
机译：简介：血友病A是最常见的遗传性出血障碍和最具挑战性的凝血障碍。为解决这一目标，最近批准了许多新的改进的RFVIII / IX精矿。其中一些来自蛋白质融合生物技术或聚乙二醇化以延长其半衰期（HL）。然而，虽然需要频繁的静脉穿刺是主要预防的主要障碍，但预防性已成为预防血友病患者中的关节病症。新的延长半衰期（EHL）RFIX浓缩物允许增加间隔，而新RFVIII的改善HL是中等的。 RFVIII SIMOCTOCOG ALFA是在人胚胎肾（HEK）细胞中产生的，并且HEK细胞进行的翻译后修饰与天然FVIII.AREAS中的那些非常相似：本文，本文提供了对其内容的综述SIMOCTOCOG ALFA包括有关Simoctocog Alfa的制造，临床试验，安全性和耐受性的信息。他们还向这项治疗提供了他们的专家意见和未来的观点.Pert意见：Simoctocog Alfa的一个重要优势是省略至少30％的veripunctures的预防。因此，每周三次推注施用的标准可能每周减少到两次，意思是每年约50个静脉穿刺。这可能对儿童特别有帮助。

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