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Jaguar Health Announces Napo Therapeutics' Submission of Orphan Drug Designation Application to the European Medicines Agency for Crofelemer for a Severe Congenital Diarrheal Disorder (CDD) Condition
Microvillus inclusion disease (MVID) is a life-threatening and rare autosomal recessive disease that affects newborns and children and leads to significant
About this update from Jaguar Health, Inc.
[{"type":"text","content":"Microvillus inclusion disease (MVID) is a life-threatening and rare autosomal recessive disease that affects newborns and children and leads to significant morbidity and mortality from severe secretory diarrheaSAN FRANCISCO, CA / ACCESSWIRE / May 25, 2022 / Jaguar Health (NASDAQ:JAGX) today announced that Napo Therapeutics, the Italian corporation established by the company in Italy in 2021 that focuses on expanding crofelemer access in Europe, has submitted an Orphan Drug Designation (ODD) application for crofelemer for a rare congenital diarrheal disorder (CDD) condition called microvillus inclusion disease (MVID) to the European Medicines Agency (EMA). The submission is the first step of the process; the review by the EMA's Committee for Orphan Medicinal Products (COMP) will start after the validation of the submission.\"CDDs are a group of inherited chronic enteropathies characterized by heterogeneous etiology, and each type of CDD is thus a different disease with a different pathogenetic mechanism,\" said Martire Particco, MD, Chief Medical Officer of Napo Therapeutics. \"MVID is a life-threatening and rare autosomal recessive disease that affects newborns and children and leads to significant morbidity and even death from severe secretory diarrhea.\"CDDs share a primary common symptom: chronic diarrhea, and therefore secondary symptoms associated with diarrhea, including significant dehydration, metabolic acidosis or alkalosis and malnutrition, among other secondary symptoms, and these symptoms expeditiously emerge and become life-threatening.Napo Therapeutics' mission is to provide access to Jaguar Health's proprietary first-in-class plant-based medicine crofelemer in Europe to address such significant rare disease indications. The company's initial focus is on clinical development and future registration in Europe of crofelemer for debilitating orphan disease target indications starting with short bowel syndrome (SBS).The evaluation process for the ODD application takes approximately 90 days from acceptance. Sponsors who obtain orphan designation for their drug can benefit from Scientific Advice from the EMA for clinical trials for the orphan indication and receive market exclusivity for a period of ten years once the medicine is approved for commercialization.\"We are very pleased that the orphan drug designation applic...