诺华宣布FDA接受Beovu治疗糖尿病黄斑水肿患者的申请

2021-10-17 Allan MedSci原创

诺华近日宣布,美国食品和药品监督管理局 (FDA) 已接受该公司的补充生物制剂许可申请 (sBLA),用于治疗糖尿病性黄斑水肿(DME)。

诺华近日宣布,美国食品和药品监督管理局 (FDA) 已接受该公司的补充生物制剂许可申请 (sBLA),用于治疗糖尿病性黄斑水肿(DME)。此外,日本药品和医疗器械机构(PMDA)也接受了 Beovu 治疗 DME 的申请。Beovu 在 DME 中的监管决定预计将于 2022 年中期在美国和欧洲作出。

如果获得批准,DME 将成为 Beovu 继 2019 年 10 月(FDA)和 2020 年 2 月(欧盟委员会)批准用于湿性年龄相关性黄斑变性之后的第二个适应症。DME 是发达国家成人失明的主要原因,影响 12% 的 1 型糖尿病患者和 28% 的 2 型糖尿病患者。与糖尿病相关的持续高血糖水平会损害眼睛中的小血管,导致它们渗漏液体。

 III 期、随机、双盲 KESTREL 和 KITE 研究的第一年数据显示,Beovu达到主要终点,即最佳矫正视力 (BCVA) 从基线到一年的变化与阿柏西普相比具有非劣效性。在 KESTREL 和 KITE 试验中,与使用阿柏西普治疗的眼睛相比,使用 Beovu 治疗的眼睛在第 32 周和第 52 周时出现视网膜内和/或视网膜下液 (IRF/SRF) 的情况较少。 KESTREL 和 KITE 试验是第一个在负荷阶段以 6 周给药间隔评估抗 VEGF 治疗的关键试验,这表明 Beovu 可能从治疗开始提供更少的注射。

总体而言,Beovu 在 KESTREL 和 KITE 中表现出良好的收益-风险状况。KESTREL 和 KITE 中最常见的眼部和非眼部不良事件(≥5%)是结膜出血、鼻咽炎和高血压。在KESTREL试验中,Beovu 3 mg的眼内炎症(IOI)率为 4.7%,Beovu 6 mg的 IOI 率为 3.7%,阿柏西普 2 mg的 IOI 率为 0.5%,这些事件中的大多数是可控的

 

原始出处:

https://www.firstwordpharma.com/node/1871208?tsid=4

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    2022-01-22 ms2000000518921303

    学习了

    0

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    2021-10-18 ms1000000534935938

    生物制剂

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    2021-10-18 小华子
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    2021-10-18 muzishouyi
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    2021-10-18 查查佳佳

    溶酶生成后迅速与a2纤溶酶抑制剂1:1结

    0

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    2021-10-17 124daa75m82(暂无昵称)

    感谢分享。

    0

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