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Jaguar Health Files Final Canalevia (Crofelemer) Technical Section for Proposed Indication of Chemotherapy-Induced Diarrhea in Dogs
Reminder: Company to Host Investor Call October 3rd at 8 a.m. Eastern to Provide Updates Regarding Development of Mytesi® (Crofelemer) for the Potential
About this update from Jaguar Health, Inc.
[{"type":"text","content":"Reminder: Company to Host Investor Call October 3rd at 8 a.m. Eastern to Provide Updates Regarding Development of Mytesi® (Crofelemer) for the Potential Follow-on Indication of Cancer Therapy-Related Diarrhea in HumansSAN FRANCISCO, CA / ACCESSWIRE / October 1, 2019 / Jaguar Health, Inc. (NASDAQ:JAGX) (\"Jaguar\" or the \"Company\") announced today that on September 30, 2019, the Company filed the Target Animal Safety technical section with the U.S. Food & Drug Administration's Center for Veterinary Medicine (CVM) for Jaguar's application for conditional approval of CanaleviaTM (crofelemer delayed-release tablets) for chemotherapy-induced diarrhea (CID) in dogs. This technical section is the last of the four major technical sections Jaguar is required to file for conditional approval of Canalevia for the proposed CID indication.\"As previously announced, the CVM has already indicated that Jaguar's Reasonable Expectation of Effectiveness Technical Section and Environmental Sections are complete for use of Canalevia for treatment of CID,\" Dr. Michael Guy, DVM, MS, PhD, Jaguar's vice president and clinical veterinarian, commented. \"With receipt of conditional approval for this indication, we expect to conduct the commercial launch of Canalevia for CID in dogs in the first half of 2020.\"Lisa Conte, Jaguar's president and CEO, stated, \"Since our July 2017 merger with Napo Pharmaceuticals, as previously announced, Jaguar's human portfolio has been, and continues to be, our core focus. However, CID is an interesting model for human medical need and is being pursued as our first prescription indication for animal health. We believe there is an important unmet medical need for the treatment of CID in dogs. Certain cancer treatment agents provided to dogs are human drugs, or have the same mechanism of action as human cancer drugs, and these agents and mechanisms of action often have meaningful rates of diarrhea in humans as well. Canalevia acts locally in the gut and is minimally absorbed systemically. It does not alter gastrointestinal motility, has no significant effects on normally-functioning intestinal ion channels or the transport of electrolytes or fluids, and has no side effects different from placebo. These features are further augmented by the lack of effects of Canalevia on the absorption and/or metabolism of co-administere...