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Jaguar Health Announces FDA Agrees with Clinical Trial Protocol for Full Approval of Canalevia-CA1 for Treatment of Chemotherapy-Induced Diarrhea (CID) in Dogs
Canalevia®-CA1 is currently FDA conditionally approved for treatment of CID in dogs and is the first and only treatment for CID in dogs to receive any type of
About this update from Jaguar Health, Inc.
[{"type":"text","content":"Canalevia®-CA1 is currently FDA conditionally approved for treatment of CID in dogs and is the first and only treatment for CID in dogs to receive any type of approval from FDABy prescription only, Canalevia-CA1 is a canine-specific formulation of crofelemer, Jaguar's novel, oral plant-based product sustainably harvested from the Croton lechleri treeSAN FRANCISCO, CA / ACCESSWIRE / February 15, 2024 / Jaguar Health, Inc. (NASDAQ:JAGX), under its Jaguar Animal Health tradename for the veterinary market, today announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) on the design and conduct of a clinical field study of Canalevia-CA1 (crofelemer delayed-release tablets), the company's FDA conditionally approved prescription drug for the treatment of chemotherapy-induced diarrhea (CID) in dogs, for full approval of the product.Canalevia-CA1 received conditional approval in December 2021 from the FDA for the treatment of CID in dogs and is available from multiple leading veterinary distributors in the U.S. Conditional approval allows for commercialization of the product while Jaguar continues to collect the substantial evidence of effectiveness required for full approval.\"We are thrilled that we have reached concurrence with the FDA on Jaguar's protocol for our planned clinical field study of Canalevia-CA1,\" said Michael Guy, DVM, MS, PhD, Jaguar Health's Vice President of Preclinical and Nonclinical Studies. \"This milestone is an important step forward on the pathway toward full approval for Canalevia-CA1. Canalevia-CA1 is an important prescription drug for the veterinary community and the thousands of dogs experiencing CID. Canalevia-CA1 can help support the comfort and quality of life of dogs while being treated with chemotherapy, which may help keep them compliant with their life-saving treatment. Receipt of concurrence from the FDA on this protocol has the additional benefit of allowing us to apply for a grant from the FDA to help defer a portion of the costs to run the planned clinical field study.\"Canalevia-CA1 is referenced in an article about new therapies in veterinary oncology published January 6, 2024 in the journal Veterinary Clinics of North America: Small Animal Practice. The article is titled \"New Therapies in Veterinary Oncology,\" and the article abstract can be accessed by clic...