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Journey Medical红斑痤疮药物Emrosi获FDA批准上市

2024-11-06


11月4日,Journey Medical宣布,FDA已批准Emrosi™(盐酸米诺环素缓释胶囊,40mg)用于治疗成人红斑痤疮的炎症性病变。

此次批准得到了两项III期临床研究的积极数据支持。受试者完成了为期16周的治疗,没有出现明显的安全性问题。在两项研究中,Emrosi在研究者总体评估”(Investigator's Global Assessment)的治疗成功率以及炎症病灶总数减少方面,均明显优于目前的标准治疗药物Orace胶囊和安慰剂。


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