Jaguar Health 与 FDA 会面,推进了一项针对罕见儿科 MVID 的 crofelemer 试验,显示出肠外支持的减少有希望。
Jaguar Health met with the FDA to advance a trial of crofelemer for rare pediatric MVID, showing promising reductions in parenteral support.
捷豹健康于 2025 年 10 月 2 日完成了与 FDA 的 C 类会议,寻求有关推进其 crofelemer 治疗微绒毛包涵体病 (MVID) 临床试验的指导,这是一种罕见的儿科疾病,影响全球 100-200 名患者,需要终身肠外支持,没有批准的治疗方法。
Jaguar Health completed a Type C meeting with the FDA on October 2, 2025, seeking guidance on advancing its clinical trial of crofelemer for microvillus inclusion disease (MVID), a rare pediatric disorder affecting 100–200 patients globally and requiring lifelong parenteral support with no approved treatments.
阿联酋正在进行的一项试验显示,恢复 crofelemer 后,总肠外支持减少了 37%,肠外营养下降了 30%,超过了之前的结果。
An ongoing UAE trial showed a 37% reduction in total parenteral support and a 30% drop in parenteral nutrition after resuming crofelemer, exceeding prior results.
该公司计划根据林业发展局的反馈修改其试验,在欧盟和中东和北非地区进行监管讨论,并在11月NASPGHAN年度会议上提出调查结果。
The company plans to amend its trial based on FDA feedback, pursue regulatory discussions in the EU and MENA regions, and present findings at the NASPGHAN Annual Meeting in November.
Crofelemer在美国和欧盟持有孤儿药物名称, Jaguar正在支持美国扩大儿童MVID患者的准入方案。
Crofelemer holds orphan drug designation in the U.S. and EU, and Jaguar is supporting expanded access programs in the U.S. for pediatric MVID patients.