Jaguar Health Announces Preliminary Discussion with FDA to Evaluate Breakthrough Therapy Designation for Crofelemer for Treatment of Microvillus Inclusion Disease (MVID)

Pediatric patients with Intestinal Failure (IF) due to MVID, an ultrarare congenital disorder with lethal natural history, that has no available therapies and needs lifelong total Parenteral Support (PS), could benefit from expedited development of oral crofelemer via Breakthrough Therapy Designation Crofelemer has demonstrated meaningful reductions in weekly PS needs in two pediatric MVID patients with initial results to be presented at ESPGHAN 2026 SAN FRANCISCO, CA / ACCESS Newswire / May 6, 2026 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar") family company Napo Pharmaceuticals Inc., announced that the Company recently held a preliminary discussion with the Division of Gastroenterology at U.S. Food and Drug Administration (FDA) to evaluate the possibility of a Breakthrough Therapy Designation (BTD) for oral liquid crofelemer as an adjunctive therapy to PS for the treatment of pediatric patients with intestinal failure (IF) due to microvillus inclusion disease (MVID), an ultrarare congenital disorder with a lethal natural history requiring lifelong PS. Crofelemer has demonstrated preliminary clinical proof of concept (POC) in pediatric MVID patients in two open-label studies, with meaningful reductions in weekly PS requirements for the two MVID patients.