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Jaguar Health Submits Final Major Regulatory Filing for Approval of Canalevia (Crofelemer) to Treat Chemotherapy-induced Diarrhea in Dogs
Canalevia would be first and only FDA-approved plant-based medicine for 50,000-plus dogs that suffer from diarrhea during chemotherapySAN FRANCISCO, CA /
About this update from Jaguar Health, Inc.
[{"type":"text","content":"Canalevia would be first and only FDA-approved plant-based medicine for 50,000-plus dogs that suffer from diarrhea during chemotherapySAN FRANCISCO, CA / ACCESSWIRE / May 28, 2020 / Jaguar Health, Inc. (NASDAQ:JAGX) (\"Jaguar\" or the \"Company\") announced today that it has submitted to the U.S. Food and Drug Administration's Center for Veterinary Medicine (CVM) what the Company expects is the final major regulatory filing to support approval of its oral plant-based drug candidate Canalevia™ (crofelemer delayed-release tablets) to treat chemotherapy-induced diarrhea (CID) in dogs.According to current estimates, more than 230,000 dogs in the U.S. receive chemotherapy treatment for various cancers each year, and roughly one in four will experience diarrhea as a side effect of treatment. There currently is no FDA-approved anti-secretory prescription product to manage this debilitating diarrhea in dogs.The filing consists of an updated version of the Target Animal Safety technical section of Jaguar's application for conditional approval of Canalevia for CID under the Minor Use/Minor Species (MU/MS) section of The Minor Use and Minor Species Animal Health Act of 2004.\"With this filing, which includes new administrative details, we are confident that CVM will deem our Target Animal Safety technical section Complete,\" said Dr. Michael Guy, DVM, Ph.D., Jaguar's vice president of preclinical and nonclinical studies.As previously announced, the technical section contains data from a 2017 safety study indicating that the NOAEL (no-observed-adverse-effect level) of Canalevia in dogs is approximately six times greater than previously demonstrated, and that Canalevia also is safe for use in puppies as young as 12 weeks of age.In addition to CID, Jaguar also is seeking conditional approval to market Canalevia for exercise-induced diarrhea (EID) in dogs. \"We are leveraging many of the same major technical sections from our CID submission for the proposed EID indication,\" Dr. Guy said. \"We expect that Canalevia could be available under conditional approval to treat both CID and EID in the first half of 2021.\"\"Jaguar is now one important step closer to having our first approved medicine for use in animals,\" said Jaguar president and chief executive officer Lisa Conte. \"We believe Canalevia will be an important treatment option for the 5...