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KRINTAFEL

NDA210795·TAFENOQUINE SUCCINATE·已获正式原始批准

首次正式批准

2018-07-20

原始申请分类

TYPE 1 · 新分子实体（NME）

当前持有企业

GLAXOSMITHKLINE

产品信息

NDA210795 · 处方药

规格与剂型

持有企业: GLAXOSMITHKLINE
活性成分: TAFENOQUINE SUCCINATE
剂型: TABLET
给药途径: ORAL
规格: EQ 150MG BASE
参比: RLD 是 · RS 是

靶点与作用机制

靶点

暂无摘录

作用机制（MoA）

暂无摘录

来源 ORIG:1

当前获批适应症（说明书）

Prevention of relapse (radical cure) of Plasmodium vivax malaria in patients aged 16 years of age and older who are receiving appropriate therapy for acute P. vivax infection。

产品号 001 · KRINTAFEL · EQ 150MG BASE · TABLET;ORAL

监管信息

审批生命周期时间轴

ORIG / NME EFFICACY LABELING CMC 其他

2020

11/16

LABELINGLABELING · 标签/说明书变更 · 标准审评 · SUPPL:1

补充批准 · 说明书变更

批准信：Prior Approval；This Prior Approval sNDA provides for updates to the prescribing information (PI) to add a limitation of use and warning related to the risk of recurrence of P. vivax malaria when KRINTAFEL is used with antimalarials …

批批准信审审评报告说说明书

展开审批详情

批准信原文要点

This Prior Approval sNDA provides for updates to the prescribing information (PI) to add a limitation of use and warning related to the risk of recurrence of P. vivax malaria when KRINTAFEL is used with antimalarials other than chloroquine.

Labeling-Package Insert（PI）

摘录（本节点）letter_ok

申报事项：说明书/标签变更（Prior Approval）

变更信息：This Prior Approval sNDA provides for updates to the prescribing information (PI) to add a limitation of use and warning related to the risk of recurrence of P. vivax malaria when KRINTAFEL is used with antimalarials …

来源：官方文件

2019

—

无公开申报节点

2018

07/20

ORIG · NMETYPE 1 · 新分子实体（NME） · 优先审评 · ORIG:1

首次正式批准 · 原始申请

批准信：KRINTAFEL (tafenoquine) 片剂获批用于 16 岁及以上、正在接受急性间日疟适当抗疟治疗的患者根治（预防复发）间日疟；并授予热带病优先审评券（PRV，section 524）。

批批准信审审评报告说说明书

展开审批详情

批准信原文要点

This new drug application provides for the use of KRINTAFEL (tafenoquine) tablets for the radical cure (prevention of relapse) of Plasmodium vivax malaria in patients aged 16 years and older who are receiving appropriate antimalarial therapy for acute P. vivax infection. We also inform you that you have been granted a tropical disease priority review voucher, as provided under section 524 of the FDCA.

摘录（本节点）审评文件摘录

本申报适应症：Prevention of relapse (radical cure) of Plasmodium vivax malaria in patients aged 16 years of age and older who are receiving appropriate therapy for acute P. vivax infection.

疾病背景介绍：P. vivax malaria is a serious condition with a worldwide burden of 130-390 million infections (~50% of malaria cases). It is characterized by a dormant liver stage (hypnozoite) that causes relapse. Current standard of care involves a 14-day course of primaquine, which has poor real-world compliance, leading to sub-optimal efficacy and continued transmission.

现有治疗手段：The standard of care for radical cure of P. vivax malaria is a schizontocidal antimalarial (usually chloroquine) combined with a 14-day course of primaquine phosphate. Primaquine is the only available drug with activity against liver hypnozoites, but adherence to the 14-day regimen is often low in real-world settings, resulting in treatment failure and relapse.

CMC：Tafenoquine is an 8-aminoquinoline antimalarial drug. The proposed dose is a single 300 mg dose (two 150 mg tablets) administered on Day 1 or Day 2 of chloroquine therapy. It has a long elimination half-life (approx. 15 days) and is contraindicated in patients with G6PD deficiency or unknown G6PD status due to the risk of hemolysis.

来源：210795Orig1s000MultidisciplineR.pdf + 210795Orig1s000OtherR.pdf · 打开摘录来源 ↗