欧洲药品管理局的人类药物委员会(CHMP)推荐八种新药

2019-03-04 不详 MedSci原创

Akcea Therapeutics的Waylivra(volanesorsen)推荐了有条件的上市许可,这是治疗家族性乳糜微粒血症综合症(FCS)的第一个获批的药物,可用于阻止FCS患者体内的脂肪(脂质)被分解。患有这种疾病的患者血液中甘油三酯水平极高,可引起一系列症状,包括严重的腹痛、急性胰腺炎、肝脾肿大、糖尿病、注意力不集中、记忆力减退和脂肪充盈斑等。

Akcea Therapeutics的Waylivra(volanesorsen)进行有条件的上市许可,这是治疗家族性乳糜微粒血症综合症(FCS)的第一个获批的药物,可用于阻止FCS患者体内的脂肪(脂质)被分解。患有这种疾病的患者血液中甘油三酯水平极高,可引起一系列症状,包括严重的腹痛、急性胰腺炎、肝脾肿大、糖尿病、注意力不集中、记忆力减退和脂肪充盈斑等。

Portola Netherlands的Ondexxya(andexanet alfa)进行有条件的营销许可,用于危及生命或不受控制的出血的解毒剂;

辉瑞的Lorviqua(洛瑞铂),用于治疗间变性淋巴瘤激酶(ALK)阳性的晚期非小细胞肺癌NSCLC);

BioMarin International的Palynziq(pegvaliase),用于治疗16岁以上苯丙酮尿症的患者;

AbbVie's Skyrizi的risankizumab,用于治疗中度至重度银屑病;

赛诺菲的Zynquista(sotagliflozin),用于治疗部分I型糖尿病患者;

GlaxoSmithKline的Dectova (zanamivir) ,在特殊情况下,用于治疗复杂且可能危及生命的流感。

Teva的通用Pazenir(紫杉醇),用于治疗转移性乳腺癌和非小细胞肺癌

从2019年3月开始,所有CHMP会议将在阿姆斯特丹新的EMA总部举行。

原始出处:


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    2019-03-06 医生2394
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