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美国食品药品监督管理局批准Aurinia Pharmaceuticals的LUPKYNIS标签更新

FDA Approves Label Update For Aurinia Pharmaceuticals' LUPKYNIS

RTTNews | 2024-04-30 | 翻译由动脉网AI生成,点击反馈

可切换为仅中文


Aurinia Pharmaceuticals Inc. (AUPH) Tuesday said the U.S. Food and Drug Administration has approved a label update for LUPKYNIS, the company's approved medicine for the treatment of adult patients with active lupus nephritis (LN).The label now includes three-year data from the AURORA 2 extension study which showed sustained complete renal response with LUPKYNIS through three years.

Aurinia Pharmaceuticals Inc.(AUPH)周二表示,美国食品和药物管理局已批准LUPKYNIS的标签更新,LUPKYNIS是该公司批准用于治疗活动性狼疮性肾炎(LN)成年患者的药物。该标签现在包括来自AURORA 2扩展研究的三年数据,该研究显示LUPKYNIS在三年内持续完全肾脏反应。

The updated label does not state that the safety and efficacy of LUPKYNIS has not been established beyond one year.The label also indicates that monthly kidney function assessment is no longer required after first year of treatment. The label had previously stated that it should be assessed every four weeks for the duration of treatment.

更新后的标签并未说明LUPKYNIS的安全性和有效性尚未确定超过一年。标签还表明,治疗第一年后不再需要每月进行肾功能评估。该标签之前曾表示,在治疗期间应每四周进行一次评估。

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