吉利德科学(GILD.US)突破性小分子药物获欧盟批准 用于治疗致命性肝病

智通财经
Feb 24

智通财经APP获悉,吉利德科学公司(GILD.US)日前宣布,欧盟委员会(EC)已有条件批准seladelpar上市,与熊去氧胆酸(UDCA)联用,治疗对UDCA单药应答不足的原发性胆汁性胆管炎(PBC)患者。或作为单药,用于对UDCA治疗不耐受的PBC患者。

Seladelpar已于2024年8月获得美国FDA的加速批准(商品名Livdelzi),用于治疗PBC。Seladelpar曾获得FDA授予的突破性疗法认定以及针对PBC患者的孤儿药资格,以及欧洲药品管理局授予的PRIME资格。作为FDA加速批准的一部分,吉利德承诺进行一项名为AFFIRM的确认性长期结局研究,该研究已在代偿期肝硬化患者中启动。

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