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<p>赛诺菲（SNY,SNYNF,SAN.PA）宣布，欧洲药品管理局（EMA）已授予 efdoralprin alfa（SAR447537，前称 INBRX-101）孤儿药资格。</p>
<p>Efdoralprin alfa 是一种研究中的重组人α-1 抗胰蛋白酶（AAT）-Fc 融合蛋白。它正在开发作为潜在的α-1 抗胰蛋白酶缺乏症（AATD）相关肺气肿的治疗方法，这是一种罕见且严重的呼吸系统疾病。</p>
<p>该资格强调了 AATD 相关肺气肿中显著的未满足医疗需求，并突显了 efdoralprin alfa 为受此疾病影响的患者提供新治疗选择的潜力。</p>
<p>美国食品和药物管理局之前已授予 efdoralprin alfa 快速通道和孤儿药资格，用于治疗 AATD 相关肺气肿。</p>
<p>Efdoralprin alfa 目前正在进行临床开发，其安全性和有效性尚未经过任何监管机构的评估。赛诺菲计划在即将召开的医学会议上展示数据，并与全球监管机构就适当的后续步骤进行沟通。</p>
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<p>赛诺菲宣布，欧洲药品管理局（EMA）已授予 efdoralprin alfa 孤儿药资格，该药物用于治疗与α-1 抗胰蛋白酶缺乏相关的肺气肿。此项资格突显了未满足的医疗需求和该药物的潜力。此前，美国 FDA 已为同一病症授予快速通道和孤儿药资格。Efdoralprin alfa 目前处于临床开发阶段，安全性和有效性尚待评估。赛诺菲计划在即将召开的医学会议上展示数据，并与全球监管机构进行沟通</p>

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</div><p>Sanofi (SNY,SNYNF,SAN.PA) announced that the European Medicines Agency (EMA) has granted orphan designation to efdoralprin alfa (SAR447537), formerly known as INBRX-101.</p>
<div class="lb-trans"><p>赛诺菲（SNY,SNYNF,SAN.PA）宣布，欧洲药品管理局（EMA）已授予 efdoralprin alfa（SAR447537，前称 INBRX-101）孤儿药资格。</p>
</div><p>Efdoralprin alfa is an investigational recombinant human alpha-1 antitrypsin (AAT)-Fc fusion protein. It is being developed as a potential treatment for alpha-1 antitrypsin deficiency (AATD)-related emphysema, a rare and serious respiratory condition.</p>
<div class="lb-trans"><p>Efdoralprin alfa 是一种研究中的重组人α-1 抗胰蛋白酶（AAT）-Fc 融合蛋白。它正在开发作为潜在的α-1 抗胰蛋白酶缺乏症（AATD）相关肺气肿的治疗方法，这是一种罕见且严重的呼吸系统疾病。</p>
</div><p>The designation highlights the significant unmet medical need in AATD-related emphysema and underscores the potential of efdoralprin alfa to provide new therapeutic options for patients affected by this condition.</p>
<div class="lb-trans"><p>该资格强调了 AATD 相关肺气肿中显著的未满足医疗需求，并突显了 efdoralprin alfa 为受此疾病影响的患者提供新治疗选择的潜力。</p>
</div><p>The US Food and Drug Administration previously granted both fast track and orphan drug designation to efdoralprin alfa for the treatment of AATD related emphysema.</p>
<div class="lb-trans"><p>美国食品和药物管理局之前已授予 efdoralprin alfa 快速通道和孤儿药资格，用于治疗 AATD 相关肺气肿。</p>
</div><p>Efdoralprin alfa is currently in clinical development, and its safety and efficacy have not been evaluated by any regulatory authority. Sanofi plans to present the data at a forthcoming medical meeting and engage with global regulatory authorities on the appropriate next steps.</p>
<div class="lb-trans"><p>Efdoralprin alfa 目前正在进行临床开发，其安全性和有效性尚未经过任何监管机构的评估。赛诺菲计划在即将召开的医学会议上展示数据，并与全球监管机构就适当的后续步骤进行沟通。</p>
</div><p>For More Such Health News, visit rttnews.com.</p>
<div class="lb-trans"><p>欲获取更多健康新闻，请访问 rttnews.com。</p>
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赛诺菲获得欧洲药品管理局（EMA）对 Efdoralprin Alfa 的孤儿药资格认定