<p><img src="https://imageproxy.pbkrs.com/https://www.pharmaceutical-technology.com/wp-content/uploads/sites/24/2025/11/PT-26-11-2025-shutterstock_2468583845-430x241.jpg?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" alt="" original-src="https://imageproxy.pbkrs.com/https://www.pharmaceutical-technology.com/wp-content/uploads/sites/24/2025/11/PT-26-11-2025-shutterstock_2468583845-430x241.jpg"/></p>
<p>Voyxact 抑制 APRIL，這是 IgA 腎病中的一個關鍵因素，降低了與其發展相關的血清致病性 Gd-IgA1 水平。來源：sasirin pamai/Shutterstock.com。</p>
<p>大冢製藥已獲得美國食品和藥物管理局（FDA）對 Voyxact（sibeprenlimab-szsi）的加速批准，以減少處於疾病進展風險的成人原發性免疫球蛋白 A 腎病（IgAN）患者的蛋白尿。</p>
<p>Voyxact 以自我注射的皮下劑量每四周給藥一次。其批准基於 III 期 VISIONARY 試驗的中期結果，該試驗在 320 名參與者中顯示，蛋白尿在九個月內的安慰劑調整減少率為 51%。</p>
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<p>這是第一種旨在阻斷 A 增殖誘導配體（APRIL）的治療。</p>
<p>蛋白尿的減少作為一個替代標誌，與延緩腎衰竭的進展相關。FDA 的批准是基於這一標誌的加速通道授予的。</p>
<p>Voyxact 對 IgAN 患者腎功能下降的長期影響尚待確定。</p>
<p>持續批准取決於正在進行的 VISIONARY III 期研究的確認，該研究評估 24 個月內通過估計的腎小管濾過率（eGFR）減少的疾病進展，數據預計在 2026 年初發布。</p>
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<p>大冢製藥執行副總裁兼首席醫療官 John Kraus 表示：“Voyxact 的可用性代表了一種新穎的靶向方法，旨在幫助管理 IgAN 患者的這一複雜疾病。</p>
<p>“憑藉其靶向機制、強大的療效、安全性和每四周一次的給藥方案，Voyxact 為 IgAN 患者提供了一種新選擇。我們認識到 IgAN 急需新的治療選擇，感謝繼續參與我們臨牀試驗計劃的患者和醫療專業人士。”</p>
<p>Voyxact 抑制 APRIL，這是 IgAN 發病機制中四重打擊過程的一個關鍵因素，促進致病性缺乏半乳糖的 IgA1（Gd-IgA1）的產生。阻斷 APRIL 降低了與 IgAN 發展相關的血清 Gd-IgA1 水平。</p>
<p>VISIONARY 是一項安慰劑對照的全球隨機雙盲研究，涉及 510 名接受標準支持治療的 IgAN 成人。</p>
<p>2025 年 5 月，美國 FDA 接受了大冢製藥的 sibeprenlimab 生物製劑許可申請 進行審查。</p>
<h2>製藥技術卓越獎 - 參賽的好處</h2>
<p>獲得你應得的認可！製藥技術卓越獎 慶祝創新、領導力和影響力。通過參賽，你展示了你的成就，提高了你的行業形象，並將自己定位在推動製藥進步的頂尖領導者之中。不要錯過脱穎而出的機會 - 今天就提交你的參賽作品！</p>
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大塚制藥(ADR)

<p>大冢製藥 (ADR) 已獲得美國 FDA 的加速批准，用於治療原發性 IgA 腎病（IgAN）成人患者的 Voyxact（sibeprenlimab-szsi），該療法旨在減少蛋白尿。Voyxact 每四周皮下給藥一次，在三期臨牀試驗中顯示出 51% 的安慰劑調整後蛋白尿減少。該批准基於蛋白尿減少作為替代標誌物，腎功能的長期影響仍在研究中。持續批准取決於預計在 2026 年獲得的進一步試驗結果</p>

<p><img src="https://imageproxy.pbkrs.com/https://www.pharmaceutical-technology.com/wp-content/uploads/sites/24/2025/11/PT-26-11-2025-shutterstock_2468583845-430x241.jpg" alt="" original-src="https://www.pharmaceutical-technology.com/wp-content/uploads/sites/24/2025/11/PT-26-11-2025-shutterstock_2468583845-430x241.jpg"/></p>
<p>Voyxact inhibits APRIL, a key factor in IgA nephropathy, reducing serum pathogenic Gd-IgA1 levels implicated in its development. Credit: sasirin pamai/Shutterstock.com.</p>
<div class="lb-trans"><p>Voyxact 抑制 APRIL，這是 IgA 腎病中的一個關鍵因素，降低了與其發展相關的血清致病性 Gd-IgA1 水平。來源：sasirin pamai/Shutterstock.com。</p>
</div><p>Otsuka Pharmaceutical has secured accelerated approval from the US Food and Drug Administration (FDA) for Voyxact (sibeprenlimab-szsi) to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at disease progression risk.</p>
<div class="lb-trans"><p>大冢製藥已獲得美國食品和藥物管理局（FDA）對 Voyxact（sibeprenlimab-szsi）的加速批准，以減少處於疾病進展風險的成人原發性免疫球蛋白 A 腎病（IgAN）患者的蛋白尿。</p>
</div><p>Voyxact is administered as a self-injected subcutaneous dose every four weeks. Its approval was based on the interim results of the Phase III VISIONARY trial, which demonstrated a 51% placebo-adjusted reduction in proteinuria at nine months in 320 participants.</p>
<div class="lb-trans"><p>Voyxact 以自我注射的皮下劑量每四周給藥一次。其批准基於 III 期 VISIONARY 試驗的中期結果，該試驗在 320 名參與者中顯示，蛋白尿在九個月內的安慰劑調整減少率為 51%。</p>
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<div class="lb-trans"><h4>LOA 和 PTSR 模型 - Crizanlizumab 在慢性腎病中的應用</h4>
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</div><p>It is the first therapy designed to block A-proliferation-inducing ligand (APRIL).</p>
<div class="lb-trans"><p>這是第一種旨在阻斷 A 增殖誘導配體（APRIL）的治療。</p>
</div><p>Proteinuria reduction serves as a surrogate marker linked to delayed progression to kidney failure. The FDA approval was granted under the accelerated pathway based on this marker.</p>
<div class="lb-trans"><p>蛋白尿的減少作為一個替代標誌，與延緩腎衰竭的進展相關。FDA 的批准是基於這一標誌的加速通道授予的。</p>
</div><p>The long-term effect of Voyxact on kidney function decline in IgAN is yet to be established.</p>
<div class="lb-trans"><p>Voyxact 對 IgAN 患者腎功能下降的長期影響尚待確定。</p>
</div><p>Continued approval depends on confirmation from the ongoing VISIONARY Phase III study, which evaluates disease progression through estimated glomerular filtration rate (eGFR) reduction at 24 months, with data anticipated in early 2026.</p>
<div class="lb-trans"><p>持續批准取決於正在進行的 VISIONARY III 期研究的確認，該研究評估 24 個月內通過估計的腎小管濾過率（eGFR）減少的疾病進展，數據預計在 2026 年初發布。</p>
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</div><p>Otsuka executive vice-president and chief medical officer John Kraus stated: “The availability of Voyxact represents a novel targeted approach to help manage this complex disease for patients living with IgAN.</p>
<div class="lb-trans"><p>大冢製藥執行副總裁兼首席醫療官 John Kraus 表示：“Voyxact 的可用性代表了一種新穎的靶向方法，旨在幫助管理 IgAN 患者的這一複雜疾病。</p>
</div><p>“With its targeted mechanism, strong efficacy, safety profile and once-every-four-weeks dosing, Voyxact offers a new option for IgAN patients. We recognise the urgent need for new treatment options for IgAN and are thankful for the patients and healthcare professionals who continue to participate in our clinical trial programme.”</p>
<div class="lb-trans"><p>“憑藉其靶向機制、強大的療效、安全性和每四周一次的給藥方案，Voyxact 為 IgAN 患者提供了一種新選擇。我們認識到 IgAN 急需新的治療選擇，感謝繼續參與我們臨牀試驗計劃的患者和醫療專業人士。”</p>
</div><p>Voyxact inhibits APRIL, a key factor in the four-hit process of IgAN pathogenesis, promoting production of pathogenic galactose-deficient IgA1 (Gd-IgA1). Blocking APRIL reduces serum Gd-IgA1 levels implicated in IgAN development.</p>
<div class="lb-trans"><p>Voyxact 抑制 APRIL，這是 IgAN 發病機制中四重打擊過程的一個關鍵因素，促進致病性缺乏半乳糖的 IgA1（Gd-IgA1）的產生。阻斷 APRIL 降低了與 IgAN 發展相關的血清 Gd-IgA1 水平。</p>
</div><p>VISIONARY is a placebo-controlled, global, randomised, double-blind study of 510 adults with IgAN on standard supportive therapy.</p>
<div class="lb-trans"><p>VISIONARY 是一項安慰劑對照的全球隨機雙盲研究，涉及 510 名接受標準支持治療的 IgAN 成人。</p>
</div><p>In May 2025, the US FDA accepted Otsuka Pharmaceutical’s biologics licence application for sibeprenlimab for review.</p>
<div class="lb-trans"><p>2025 年 5 月，美國 FDA 接受了大冢製藥的 sibeprenlimab 生物製劑許可申請 進行審查。</p>
</div><h2>Pharmaceutical Technology Excellence Awards - The Benefits of Entering</h2>
<div class="lb-trans"><h2>製藥技術卓越獎 - 參賽的好處</h2>
</div><p>Gain the recognition you deserve! The Pharmaceutical Technology Excellence Awards celebrate innovation, leadership, and impact. By entering, you showcase your achievements, elevate your industry profile, and position yourself among top leaders driving pharmaceutical advancements. Don’t miss your chance to stand out—submit your entry today!</p>
<div class="lb-trans"><p>獲得你應得的認可！製藥技術卓越獎 慶祝創新、領導力和影響力。通過參賽，你展示了你的成就，提高了你的行業形象，並將自己定位在推動製藥進步的頂尖領導者之中。不要錯過脱穎而出的機會 - 今天就提交你的參賽作品！</p>
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FDA 授予大冢製藥 (ADR) 的 IgAN 療法加速批准