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Jaguar Health Completes Final Regulatory Filing for Conditional New Animal Drug Approval of Canalevia (Crofelemer) to Treat Exercise-induced Diarrhea (EID) in Dogs
Canalevia® Would Be the First and Only Treatment for EID in Dogs To Receive Any Type of Approval From FDASAN FRANCISCO, CA / ACCESSWIRE / May 3, 2022 / Jaguar
About this update from Jaguar Health, Inc.
[{"type":"text","content":"Canalevia® Would Be the First and Only Treatment for EID in Dogs To Receive Any Type of Approval From FDASAN FRANCISCO, CA / ACCESSWIRE / May 3, 2022 / Jaguar Health, Inc. (NASDAQ:JAGX), under its Jaguar Animal Health tradename for the veterinary market, today announced that it has completed filing of the final regulatory section with the U.S. Food and Drug Administration's (FDA) Center for Veterinary Medicine (CVM) to support conditional new animal drug approval of the company's oral plant-based drug candidate Canalevia (crofelemer delayed-release tablets) to treat exercise-induced diarrhea (EID) in dogs.In December of 2021, Jaguar Animal Health received conditional approval from the FDA for Canalevia®-CA1 for chemotherapy-induced diarrhea (CID) in dogs. Conditional approval is an FDA drug approval pathway for animal products under The Minor Use and Minor Species (MUMS) Animal Health Act of 2004.\"We leveraged many of the same technical sections from our successful CID submission for the proposed EID indication,\" said Michael Guy, DVM, MS, Ph.D., Jaguar Health's vice president of preclinical and nonclinical studies. \"We expect that Canalevia could receive FDA conditional approval, under the name Canalevia®-CA2, to treat EID in dogs in the fourth quarter of 2022.\"Working dogs, including search and rescue, military, and sled dogs, often suffer diarrhea as a result of engaging in long periods of intense, off-leash exercise. \"Elite athletes of all species tend to have more diarrhea than their healthy though more sedentary counterparts, which can interfere with peak physical performance,\" said Michael Davis, DVM, Ph.D., DACVIM, DACVSMR, a veterinary physiologist and board-certified specialist in veterinary internal medicine and veterinary sports medicine at Oklahoma State University, where he conducts research on animal exercise physiology and performance. \"There is a significant need in the world of working dogs for a safe and effective medicine that can reduce the incidence and severity of exercise-induced diarrhea without affecting performance.\"As previously announced, the CVM has already confirmed the completeness of three of the four major required technical sections of Jaguar Animal Health's application for conditional approval of Canalevia for EID.About Jaguar Health, Jaguar Animal Health, Napo Pharmaceuticals, & Napo ...