Business
Jaguar Health Makes Submission to EMA Regarding EU Approval Pathway for Canalevia for General Diarrhea in Dogs Based on Data from Completed Study
Jaguar's requesting advice from EMA on EU approval pathway for general diarrhea of FDA conditionally approved Canalevia® A novel non-antibiotic approach to diarrhea treatment is important because there are no FDA-approved drugs to treat general ...
About this update from Jaguar Health, Inc.
[{"type":"text","content":"Jaguar's requesting advice from EMA on EU approval pathway for general diarrhea of FDA conditionally approved Canalevia®","length":132,"tagName":"p"},{"type":"text","content":"A novel non-antibiotic approach to diarrhea treatment is important because there are no FDA-approved drugs to treat general diarrhea in dogs, the second most common reason for visits to veterinary emergency hospitals","length":216,"tagName":"p"},{"type":"text","content":"SAN FRANCISCO, CA / ACCESS Newswire / December 2, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar), today announced that its Italian subsidiary, Napo Therapeutics S.p.A., has submitted a request to the European Medicines Agency (EMA) to have the EMA's Committee for Veterinary Medicinal Products (CVMP) provide scientific advice regarding the company's plan to pursue approval of Canalevia (crofelemer delayed-release tablets) in the European Union for treatment of general diarrhea in dogs based on data from a study Jaguar completed in 200 dogs in 2017. The request asks that the CVMP review the company's plan and related data during the CVMP's scheduled meeting in March 2026.","length":697,"tagName":"p"},{"type":"text","content":"The EMA is the EU's equivalent of the U.S. Food and Drug Administration (FDA). Canalevia, under the name Canalevia-CA1, is conditionally approved by the FDA as an oral prescription drug for the treatment of chemotherapy-induced diarrhea (CID) in dogs.","length":255,"tagName":"p"},{"type":"text","content":""In the study of 200 dogs with general diarrhea, the pre-specified primary endpoint was not met. However, an updated analysis using a simplified endpoint - defining treatment success as no further episodes of diarrhea after the first treatment - showed that dogs treated with Canalevia had significantly better outcomes than those receiving placebo, including fewer watery stools and improved fecal scores," said Dr. Michael Guy, D.V.M., M.S., Ph.D., Jaguar's Vice President of Preclinical and Nonclinical Studies.","length":528,"tagName":"p"},{"type":"text","content":""We provided the CVMP with a summary of the updated analysis of the data from our completed study, which we look forward to having the CVMP review," Dr. Guy said. "Following the start of the procedure in mid-January, the EMA will have 60 days (ext...