金吾财讯 | 艾伯维（ABBV）旗下艾尔建美学宣布，美国FDA已受理保妥适（BOTOXCosmetic，A型肉毒毒素）的补充生物制品许可申请，申请用于改善成人显著至重度咬肌突出，若获批，将成为美国市场首款针对该适应症的肉毒毒素产品，同时也是保妥适的第五个医美适应症。本次申报依托两项三期临床试验M21-416、M21-417，两项研究均达成主要终点，相较安慰剂组，受试者咬肌突出症状获得统计学意义上的显著改善。试验安全性数据与保妥适既往已知表现保持一致，未出现新增安全风险；接受药物治疗的受试者当中，表示“非常满意”或“满意”的人数为安慰剂组两倍。官方同时重申该产品黑框警告，需警惕毒素远处扩散等相关安全风险。该适应症落地后，将为医美医生与患者提供经过临床验证的非手术瘦脸方案，拓展保妥适在下半张脸的临床应用场景。保妥适目前在美国已获批眉间纹、鱼尾纹、额头纹、颈阔肌带四大医美适应症。艾伯维表示，本次申报是对成熟产品潜力的进一步挖掘，以此匹配不断变化的求美者需求。作为医美赛道重磅单品，新适应症如若获批，有望进一步巩固艾尔建美学在注射医美领域的市场地位。
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