Jaguar Health receives Orphan Drug Designation for crofelemer in MVID

Jaguar Health announced that the U.S. Food and Drug Administration granted Orphan Drug Designation to crofelemer for the indication of microvillus inclusion disease, a rare congenital diarrheal disorder condition, following review of the ODD application the Company submitted to the FDA. CDD and SBS are the initial focus of Napo Therapeutics, the Italian corporation established by Jaguar in Milan, Italy in 2021 with a mission to expand crofelemer access in Europe for the treatment and management of orphan and rare disease indications. Jaguar is currently supporting investigator-initiated proof-of-concept studies of crofelemer in patients with SBS or CDD with intestinal failure, focused on obtaining proof-of-concept of reduction of requirements of parenteral support including parenteral nutrition and/or intravenous fluids, throughout 2023. In accordance with the guidelines of specific European Union countries, publications of POC data from these trials could support early patient access to crofelemer for SBS or CDD with intestinal failure in 2023 through programs in Europe. Early access programs are revenue generating, and reimbursable for participating patients.