<p><img src="https://imageproxy.pbkrs.com/https://www.pharmaceutical-technology.com/wp-content/uploads/sites/24/2026/01/PT-2-08-01-2025-430x241.jpg?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" alt="" width="430" height="241" original-src="https://imageproxy.pbkrs.com/https://www.pharmaceutical-technology.com/wp-content/uploads/sites/24/2026/01/PT-2-08-01-2025-430x241.jpg"/></p>
<p>新套件包含 100 毫升输注用水，并包括 nextaro 重构装置。来源：Octapharma / PRNewswire。</p>
<p>Octapharma 已获得美国食品药品监督管理局（FDA）对新 2 克（g）Fibryga 配方的批准，用于治疗获得性纤维蛋白原缺乏症（AFD）患者。</p>
<p>该批准为医疗服务提供者提供了一个额外的选择，除了现有的 1 克版本。</p>
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<p>新套件包含 100 毫升输注用水（WFI），并包括 nextaro 重构装置，能够在紧急临床环境中简化准备过程并增加剂量灵活性。</p>
<p>Fibryga 被认为是唯一获得 FDA 批准用于 AFD 的病毒灭活人血浆来源纤维蛋白原浓缩物。</p>
<p>其冻干粉末形式使得在护理现场能够快速重构，提供了传统上使用的冷沉淀物的替代品，尽管其存在已知的局限性。</p>
<p>扩展的产品线建立在 Fibryga 在 2024 年获得 FDA 对 AFD 的早期批准基础上。该批准得到了发表在 JAMA 上的 FIBRES 研究的支持。</p>
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<p>Octapharma 总裁 Flemming Nielsen 表示：“2 克 Fibryga 套件的推出是对管理危重出血的临床医生需求的直接回应。通过简化准备过程和扩大剂量灵活性，我们帮助提供者在每一秒都至关重要的时刻更快、更准确地采取行动。”</p>
<p>Octapharma 医疗事务副总裁 Huub Kreuwel 表示：“Octapharma 继续投资于改善严重出血并发症患者结果的创新。新的 2 克 Fibryga 套件是我们重新定义止血护理标准的又一步。”</p>
<p>Fibryga 已获得美国批准，用作先天性和获得性纤维蛋白原缺乏症患者的纤维蛋白原补充剂。</p>
<p>适应症包括对获得性纤维蛋白原缺乏症患者的补充，以及对先天性纤维蛋白原缺乏症患者（包括无纤维蛋白血症和低纤维蛋白血症）急性出血事件的治疗。</p>

<p>Octapharma 已获得 FDA 批准，推出用于获得性纤维蛋白原缺乏症（AFD）患者的新 2g 配方 Fibryga。该新套件包括 100ml 的输注用水和 nextaro 重构装置，提高了在紧急临床环境中的制备和剂量灵活性。Fibryga 是美国唯一获得批准的病毒灭活人血浆来源纤维蛋白原浓缩液，为传统冷沉淀提供了更快速的替代方案。此次批准旨在改善严重出血并发症患者的治疗效果</p>

<p><img src="https://imageproxy.pbkrs.com/https://www.pharmaceutical-technology.com/wp-content/uploads/sites/24/2026/01/PT-2-08-01-2025-430x241.jpg" alt="" original-src="https://www.pharmaceutical-technology.com/wp-content/uploads/sites/24/2026/01/PT-2-08-01-2025-430x241.jpg"/></p>
<p>The new kit contains 100ml Water for Infusion and includes the nextaro reconstitution device. Credit: Octapharma / PRNewswire.</p>
<div class="lb-trans"><p>新套件包含 100 毫升输注用水，并包括 nextaro 重构装置。来源：Octapharma / PRNewswire。</p>
</div><p>Octapharma has received approval from the US Food and Drug Administration (FDA) for a new 2-gram (g) formulation of Fibryga for use in patients with acquired fibrinogen deficiency (AFD).</p>
<div class="lb-trans"><p>Octapharma 已获得美国食品药品监督管理局（FDA）对新 2 克（g）Fibryga 配方的批准，用于治疗获得性纤维蛋白原缺乏症（AFD）患者。</p>
</div><p>The approval offers healthcare providers with an additional option alongside the existing 1g version.</p>
<div class="lb-trans"><p>该批准为医疗服务提供者提供了一个额外的选择，除了现有的 1 克版本。</p>
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</div><p>The new kit contains 100ml Water for Infusion (WFI) and includes the nextaro reconstitution device, enabling streamlined preparation and increased dosing flexibility in urgent clinical settings.</p>
<div class="lb-trans"><p>新套件包含 100 毫升输注用水（WFI），并包括 nextaro 重构装置，能够在紧急临床环境中简化准备过程并增加剂量灵活性。</p>
</div><p>Fibryga is said to be the sole virus-inactivated, human plasma-derived fibrinogen concentrate that received approval for AFD in the US.</p>
<div class="lb-trans"><p>Fibryga 被认为是唯一获得 FDA 批准用于 AFD 的病毒灭活人血浆来源纤维蛋白原浓缩物。</p>
</div><p>Its lyophilised powder form enables quick reconstitution at the point of care, offering a substitute for cryoprecipitate, which has traditionally been used despite recognised limitations.</p>
<div class="lb-trans"><p>其冻干粉末形式使得在护理现场能够快速重构，提供了传统上使用的冷沉淀物的替代品，尽管其存在已知的局限性。</p>
</div><p>The expanded product line builds on Fibryga’s earlier FDA approval in 2024 for AFD. This approval was supported by the FIBRES study published in JAMA.</p>
<div class="lb-trans"><p>扩展的产品线建立在 Fibryga 在 2024 年获得 FDA 对 AFD 的早期批准基础上。该批准得到了发表在 JAMA 上的 FIBRES 研究的支持。</p>
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</div><p>Octapharma president Flemming Nielsen said: “The introduction of the 2g Fibryga kit is a direct response to the needs of clinicians managing critical bleeding. By simplifying preparation and expanding dosing flexibility, we’re helping providers act faster and more precisely – when every second counts.”</p>
<div class="lb-trans"><p>Octapharma 总裁 Flemming Nielsen 表示：“2 克 Fibryga 套件的推出是对管理危重出血的临床医生需求的直接回应。通过简化准备过程和扩大剂量灵活性，我们帮助提供者在每一秒都至关重要的时刻更快、更准确地采取行动。”</p>
</div><p>Octapharma medical affairs vice-president Huub Kreuwel said: “Octapharma continues to invest in innovations that improve outcomes for patients with serious bleeding complications. The new 2g Fibryga kit is another step forward in our mission to redefine the standard of care in haemostasis.”</p>
<div class="lb-trans"><p>Octapharma 医疗事务副总裁 Huub Kreuwel 表示：“Octapharma 继续投资于改善严重出血并发症患者结果的创新。新的 2 克 Fibryga 套件是我们重新定义止血护理标准的又一步。”</p>
</div><p>Fibryga has received approval in the US for use as fibrinogen supplementation in patients with congenital as well as acquired fibrinogen deficiency.</p>
<div class="lb-trans"><p>Fibryga 已获得美国批准，用作先天性和获得性纤维蛋白原缺乏症患者的纤维蛋白原补充剂。</p>
</div><p>Indications include supplementation for bleeding patients with acquired fibrinogen deficiency, as well as treatment of acute bleeding episodes in those with congenital fibrinogen deficiency, including afibrinogenaemia and hypofibrinogenaemia.</p>
<div class="lb-trans"><p>适应症包括对获得性纤维蛋白原缺乏症患者的补充，以及对先天性纤维蛋白原缺乏症患者（包括无纤维蛋白血症和低纤维蛋白血症）急性出血事件的治疗。</p>
</div>

Octapharma 获得 FDA 批准用于 AFD 的新型 Fibryga 配方