默克向FDA申请,将Belsomra用于治疗阿尔茨海默氏症患者的睡眠障碍

2020-02-04 不详 MedSci原创m

默克公司向FDA申请批准其失眠药物Belsomra的新适应症,用于治疗轻度至中度阿尔茨海默氏病患者的睡眠障碍。

默克公司向FDA申请批准其失眠药物Belsomra的新适应症,用于治疗轻度至中度阿尔茨海默氏病患者的睡眠障碍。

Belsomra(suvorexant)自2014年以来已获批用于治疗以入睡困难为特征的一般人群的失眠症,成为靶向orexin新型药物中的第一种,orexin是一种参与调节睡眠周期的大脑化学物质。

Eisai最近获批的Dayvigo(lemborexant)正在阿尔茨海默氏症相关的睡眠障碍中进行测试,并在2018年的第二阶段试验中报告了阳性结果。

患有阿尔茨海默氏症的人通常会经历睡眠不足和昼夜节律紊乱,从而导致夜间活动和白天嗜睡。据估计,睡眠障碍会影响多达25%的轻度至中度痴呆症患者和50%的重度痴呆症患者,随着痴呆症严重程度的提高,症状往往会加重。

Belsomra在阿尔茨海默氏症中的作用在一项由285名受试者组成的为期四周的睡眠研究中得到了证明,该研究发现与安慰剂相比,总睡眠时间(TST)和入睡后醒来(WASO)有了显着改善。

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    2020-02-06 FukaiBao

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阿斯利康和默克的PARP抑制剂Lynparza获FDA批准,用作晚期胰腺癌的维持治疗

阿斯利康和默克的PARP抑制剂Lynparza已获得FDA的批准,用作BRCA突变、经铂类化学疗法治疗后尚未进展的晚期胰腺癌(一种众所周知的难以治疗的癌症)的维持疗法。

默克的Keytruda成为美国批准用于治疗非肌肉浸润性膀胱癌的抗PD-1治疗药物

美国食品药物管理局于周三批准了默克的Keytruda(pembrolizumab),用于对卡介苗(BCG)不应答、高风险的、有或无乳头状瘤、不适合或已决定不进行膀胱切除术的非肌层浸润性膀胱癌(NMIBC)原位癌(CIS)患者。

默克针对革兰氏阴性菌感染的抗生素组合Recarbrio,获得FDA的优先审查

美国食品和药物管理局(FDA)已开始对默克的抗生素组合药物Recarbrio进行审查,该药可为难以治疗的革兰氏阴性菌感染提供新的选择。

默克的PD-1单抗Keytruda获得国内非小细胞肺癌适应症的第三次批准

默克(Merck)的重磅药物PD-1单抗Keytruda在不到一年的时间内就获得了国内非小细胞肺癌(NSCLC)治疗的第三项一线批准。

默克和辉瑞的抗PD-L1单抗Bavencio改善了局部晚期或转移性尿路上皮癌患者的生存率:III期临床达到主要终点

默克和辉瑞公司周一宣布,其PD-L1单抗新药Bavencio(avelumab)用于先前未经治疗的局部晚期或转移性尿路上皮癌患者一线维持治疗的III期研究在中期分析达到了其总体生存率(OS)的主要终点。两家公司指出,在这种情况下,抗PD-L1单抗是首个显着延长OS的免疫疗法。