Crofelemer Shows Potential for Expedited Approval in Treating MVID

Jaguar Health, Inc. has taken a significant step towards the potential expedited approval of crofelemer for treating microvillus inclusion disease (MVID). The company announced the submission of an amended protocol to the U.S. Food and Drug Administration for their ongoing clinical trial. The disease, characterized by a severe inability to absorb nutrients, demands constant parenteral support, posing life-threatening challenges for patients.

The ongoing trials have shown that crofelemer could reduce parenteral support needs by up to 37%, promising an improvement in quality of life. Jaguar Health performed trials in the United Arab Emirates and has engaged with the European Medicines Agency to explore approval pathways there as well. The global prevalence of MVID is estimated at only 100-200 patients, making these studies potentially pivotal.