<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 毫升輸注用水，幷包括 nextaro 重構裝置。來源：Octapharma / PRNewswire。</p>
<p>Octapharma 已獲得美國食品藥品監督管理局（FDA）對新 2 克（g）Fibryga 配方的批准，用於治療獲得性纖維蛋白原缺乏症（AFD）患者。</p>
<p>該批准為醫療服務提供者提供了一個額外的選擇，除了現有的 1 克版本。</p>
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<p>新套件包含 100 毫升輸注用水（WFI），幷包括 nextaro 重構裝置，能夠在緊急臨牀環境中簡化準備過程並增加劑量靈活性。</p>
<p>Fibryga 被認為是唯一獲得 FDA 批准用於 AFD 的病毒滅活人血漿來源纖維蛋白原濃縮物。</p>
<p>其凍乾粉末形式使得在護理現場能夠快速重構，提供了傳統上使用的冷沉澱物的替代品，儘管其存在已知的侷限性。</p>
<p>擴展的產品線建立在 Fibryga 在 2024 年獲得 FDA 對 AFD 的早期批准基礎上。該批准得到了發表在 JAMA 上的 FIBRES 研究的支持。</p>
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<p>Octapharma 總裁 Flemming Nielsen 表示：“2 克 Fibryga 套件的推出是對管理危重出血的臨牀醫生需求的直接回應。通過簡化準備過程和擴大劑量靈活性，我們幫助提供者在每一秒都至關重要的時刻更快、更準確地採取行動。”</p>
<p>Octapharma 醫療事務副總裁 Huub Kreuwel 表示：“Octapharma 繼續投資於改善嚴重出血併發症患者結果的創新。新的 2 克 Fibryga 套件是我們重新定義止血護理標準的又一步。”</p>
<p>Fibryga 已獲得美國批准，用作先天性和獲得性纖維蛋白原缺乏症患者的纖維蛋白原補充劑。</p>
<p>適應症包括對獲得性纖維蛋白原缺乏症患者的補充，以及對先天性纖維蛋白原缺乏症患者（包括無纖維蛋白血癥和低纖維蛋白血癥）急性出血事件的治療。</p>

<p>Octapharma 已獲得 FDA 批准，推出用於獲得性纖維蛋白原缺乏症（AFD）患者的新 2g 配方 Fibryga。該新套件包括 100ml 的輸注用水和 nextaro 重構裝置，提高了在緊急臨牀環境中的製備和劑量靈活性。Fibryga 是美國唯一獲得批准的病毒滅活人血漿來源纖維蛋白原濃縮液，為傳統冷沉澱提供了更快速的替代方案。此次批准旨在改善嚴重出血併發症患者的治療效果</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 毫升輸注用水，幷包括 nextaro 重構裝置。來源：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 已獲得美國食品藥品監督管理局（FDA）對新 2 克（g）Fibryga 配方的批准，用於治療獲得性纖維蛋白原缺乏症（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>該批准為醫療服務提供者提供了一個額外的選擇，除了現有的 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 毫升輸注用水（WFI），幷包括 nextaro 重構裝置，能夠在緊急臨牀環境中簡化準備過程並增加劑量靈活性。</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 被認為是唯一獲得 FDA 批准用於 AFD 的病毒滅活人血漿來源纖維蛋白原濃縮物。</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>其凍乾粉末形式使得在護理現場能夠快速重構，提供了傳統上使用的冷沉澱物的替代品，儘管其存在已知的侷限性。</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>擴展的產品線建立在 Fibryga 在 2024 年獲得 FDA 對 AFD 的早期批准基礎上。該批准得到了發表在 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 總裁 Flemming Nielsen 表示：“2 克 Fibryga 套件的推出是對管理危重出血的臨牀醫生需求的直接回應。通過簡化準備過程和擴大劑量靈活性，我們幫助提供者在每一秒都至關重要的時刻更快、更準確地採取行動。”</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 醫療事務副總裁 Huub Kreuwel 表示：“Octapharma 繼續投資於改善嚴重出血併發症患者結果的創新。新的 2 克 Fibryga 套件是我們重新定義止血護理標準的又一步。”</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 已獲得美國批准，用作先天性和獲得性纖維蛋白原缺乏症患者的纖維蛋白原補充劑。</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>適應症包括對獲得性纖維蛋白原缺乏症患者的補充，以及對先天性纖維蛋白原缺乏症患者（包括無纖維蛋白血癥和低纖維蛋白血癥）急性出血事件的治療。</p>
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Octapharma 獲得 FDA 批准用於 AFD 的新型 Fibryga 配方