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Jaguar Health Family Company Napo Pharmaceuticals to Meet with FDA to Discuss Potential Regulatory Pathways for Crofelemer for Treatment of Ultrarare Pediatric Indication Microvillus Inclusion Disease (MVID)
As announced, initial proof-of-concept results from the ongoing investigator-initiated trial in Abu Dhabi show crofelemer reduced the required total parenteral nutrition in the first participating MVID patient by up to 27%; abstract describing results ...
About this update from Jaguar Health, Inc.
[{"type":"text","content":"As announced, initial proof-of-concept results from the ongoing investigator-initiated trial in Abu Dhabi show crofelemer reduced the required total parenteral nutrition in the first participating MVID patient by up to 27%; abstract describing results accepted for presentation at upcoming North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) 2025 Annual Meeting in Chicago","length":411,"tagName":"p"},{"type":"text","content":"SAN FRANCISCO, CA / ACCESS Newswire / August 19, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar) family company Napo Pharmaceuticals (Napo) today announced that it plans to meet with the U.S. Food and Drug Administration (FDA) to discuss the company's ongoing clinical development program for crofelemerfor the treatment of microvillus inclusion disease (MVID), an ultrarare pediatric disorder. Members of Napo's Scientific Advisory Board will join Napo and Jaguar representatives at the meeting.","length":506,"tagName":"p"},{"type":"text","content":""We're very pleased that Napo has been granted a meeting with the FDA to discuss Napo's development plans for crofelemer for MVID - a devastating pediatric disease characterized by severe malabsorption that requires life-sustaining parenteral support to meet the nutritional, fluid and electrolyte requirements of the child, and for which there no approved drug treatments," said Pravin Chaturvedi, PhD, Napo's and Jaguar's Chief Scientific Officer and Chair of the Scientific Advisory Board. "A core Napo goal for this meeting is to obtain input from the FDA on the clinical program and potential expedited regulatory pathways for this rare orphan indication."","length":697,"tagName":"p"},{"type":"text","content":"As announced, and as presented April 26, 2025 at the Annual ELITE PED-GI Congress, the initial proof-of-concept results of the ongoing investigator-initiated trial (IIT) of a novel crofelemer powder formulation for oral solution in Abu Dhabi in the United Arab Emirates show that crofelemer reduced the required total parenteral nutrition (TPN) and supplementary intravenous fluids in the first participating MVID patient by up to 27%. An abstract describing the initial results of this trial has been accepted for presentation at the upcoming North American Society for Pediatric Gastroe...