江苏威凯尔新药维卡格雷获得FDA的临床许可
Published Time:
2021-10-14 11:06
Source:
近日，江苏威凯尔医药科技有限公司(下称：江苏威凯尔)抗血小板新药维卡格雷再传喜讯：美国食品药品管理局(FDA)已对我公司递交的维卡格雷新药临床研究申请(IND)进行反馈，允许公司开展临床试验。
维卡格雷在国内已完成二期临床研究。现有临床试验结果已显示出起效快、剂量低、无明显呼吸抑制副作用、低出血风险以及克服“氯吡格雷抵抗”等多项优势。除在急性冠脉综合征应用外，在对出血风险更敏感的脑卒中患者中有望进一步拓展相关适应症。获得FDA临床许可后，我们将启动多项国际多中心临床研究。
江苏威凯尔联合创始人兼CEO龚彦春博士表示：“维卡格雷在美国获得IND批准是其临床开发进程中一个重要里程碑，也是进军国际的第一步。感谢威凯尔团队十年如一日的辛勤付出。此前的Pre-IND会议进展顺利，FDA方面对维卡格雷给予了高度评价与赞赏。接下来我们将与临床试验单位和监管机构密切合作，加速维卡格雷的开发，争取早日为心血管疾病患者提供这一更有效的治疗方案。”
关于维卡格雷
维卡格雷是江苏威凯尔医药科技有限公司与中国药科大学的产学研合作项目，公司拥有该项目的完整权益和知识产权。项目研究成果已陆续发表于国内外多个核心期刊，并被《Nature》旗下刊物《SciBX》亮点推荐，将维卡格雷评为“该新药领域中最有商业化前景的项目之一”。中华医学会心血管病分会主任委员、中国医师协会心血管内科医师分会名誉会长、北部战区总医院(原沈阳军区总医院)韩雅玲院士作为项目PI，指导临床团队完成维卡格雷Ⅱ期等多项关键临床研究，并给予高度评价，即将在国内启动Ⅲ期临床试验。
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