【诺华盐酸伊普可泮胶囊获美国FDA常规批准】诺华近日宣布,美国食品药品监督管理局已授予盐酸伊普可泮胶囊常规批准,用于减缓存在疾病进展风险的成人原发性免疫球蛋白A肾病患者的肾功能下降。盐酸伊普可泮胶囊是一款同类首创的补体抑制剂,此前已于2024年8月获得FDA的加速批准,用于降低原发性IgAN患者的蛋白尿。本次批准在FDA授予的优先审评资格下完成。
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