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Tuesday, February 28, 2023

Jaguar Gets Orphan Tag for 2nd Rare Disease Indication

  Jaguar Health (NASDAQ:JAGX) ("Jaguar" or the "Company") today announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to crofelemer for the indication of microvillus inclusion disease (MVID), a rare congenital diarrheal disorder (CDD) condition, following review of the ODD application the Company submitted to the FDA.

"This is another very welcome development for our oral botanical drug, crofelemer, a new molecular entity that now holds four orphan designations, as crofelemer previously received ODD for MVID from the European Medicines Agency (EMA) and for short bowel syndrome (SBS) from both the FDA and the EMA," said Lisa Conte, Jaguar's president and CEO.

https://www.biospace.com/article/releases/fda-grants-orphan-drug-designation-to-jaguar-health-for-crofelemer-for-microvillus-inclusion-disease-mvid-a-second-rare-disease-indication-in-the-us/

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