European medicines agency grants orphan drug designation for crofelemer for microvillus inclusion disease (mvid), a second rare disease indication

Mvid, a rare congenital diarrheal disorder (cdd) condition, is a life-threatening autosomal recessive disease that affects newborns and children and leads to significant morbidity and mortality from intestinal failure, including severe secretory diarrhea presentation expected in december 2022 of initial results of an investigator-initiated proof-of-concept trial of crofelemer for cdd and short bowel syndrome (sbs) with intestinal failure, supporting the potential for expanded patient access to crofelemer in 2023 in europe pravin chaturvedi, phd, jaguar's chief scientific officer and chair of the scientific advisory board, receives first boston biotechnology summit lifetime achievement award san francisco, ca / accesswire / october 17, 2022 / jaguar health (nasdaq:jagx) and napo therapeutics, the italian corporation established by jaguar health in italy in 2021 that focuses on development and commercialization of crofelemer in orphan and rare diseases, thus expanding access to crofelemer to patients in europe, today announced that the european commission has adopted the decision to grant orphan drug designation (odd) for crofelemer for the indication of microvillus inclusion disease (mvid), a rare congenital diarrheal disorder (cdd) condition, in the european union following review of the odd application napo therapeutics submitted to the european medicines agency (ema) in may 2022. "this is a very welcome development for crofelemer, a new molecular entity that has been granted two orphan designations by the ema in less than one year, as crofelemer received odd for short bowel syndrome (sbs) from the ema in december 2021," said massimo mineo, ceo of napo therapeutics.
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