Expedited approval pathway
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Jaguar Health Reports Approval of All Proposals at December 2025 Special Meeting of Stockholders
Accessnewswire· 2025-12-08 21:15
Core Insights - Jaguar Health, Inc. is presenting updates on near-term catalysts at the Emerging Growth Conference on December 10, 2025 [1] - Initial results from an ongoing proof-of-concept trial indicate that crofelemer may extend the lives of infants with intestinal failure due to microvillus inclusion disease (MVID) by reducing the necessary total parenteral support (PS) volume, with a significant PS reduction of up to 37% [1] - There are currently no approved treatments for MVID, highlighting the potential market opportunity for crofelemer [1] - The company completed a meeting with the FDA on October 2, 2025, to discuss advancing its placebo-controlled trial of crofelemer, aiming for a possible expedited approval pathway for MVID treatment [1] - The company held a Special Meeting of Stockholders on December 8, 2025, where three proposals were submitted and approved [1]
In Support of Possible Expedited Approval Pathway for Crofelemer for Treatment of Microvillus Inclusion Disease (MVID), Jaguar Health Submits Amended Protocol to FDA for Ongoing Placebo-Controlled Clinical Trial
Accessnewswire· 2025-11-20 14:00
Core Insights - Crofelemer has the potential to extend the lives of patients with microvillus inclusion disease (MVID), a rare genetic disorder affecting infants and children [1] - The company has submitted an amended protocol to the FDA for a placebo-controlled clinical trial of crofelemer in pediatric MVID patients, aiming for expedited approval [1] - MVID patients face a lethal natural history and require parenteral support, which can be reduced by up to 37% with crofelemer, marking a significant breakthrough [1] Company Developments - Jaguar Health, Inc. and its subsidiary Napo Pharmaceuticals are actively pursuing the development of crofelemer for treating intestinal failure in MVID patients [1] - The ongoing clinical trial is a critical step towards obtaining approval for a treatment that currently has no approved options in any region [1] Industry Context - The lack of approved treatments for MVID highlights a significant unmet medical need in the pediatric population affected by this disorder [1] - The potential reduction of parenteral support by crofelemer could alleviate associated toxicities and comorbidities, improving the quality of life for these patients [1]