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Jaguar Health Submits Final 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 the more than 50,000 dogs that suffer from diarrhea during chemotherapySAN FRANCISCO,
About this update from Jaguar Health, Inc.
[{"type":"text","content":"Canalevia would be first and only FDA-approved plant-based medicine for the more than 50,000 dogs that suffer from diarrhea during chemotherapySAN FRANCISCO, CA / ACCESSWIRE / August 18, 2020 / Jaguar Health, Inc. (NASDAQ:JAGX) announced today that it has submitted to the U.S. Food and Drug Administration's Center for Veterinary Medicine (CVM) the last required technical section to support approval of Jaguar's 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 (more than 50,000 dogs) will experience diarrhea as a side effect of treatment. There currently is no FDA-approved anti-secretory prescription product to manage this type of debilitating diarrhea in dogs.The filing consists of the minor Labeling 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.\"Managing this type of debilitating diarrhea in dogs undergoing cancer treatment is not only a comfort issue for dogs, it may also help dogs better tolerate their chemotherapy once CID is under control and improve the home and living environment for dog owners,\" said Jaguar president and chief executive officer - and parent of two Jack Russell Terriers - Lisa Conte. \"For these reasons, we believe Canalevia will be an important treatment option for veterinary healthcare teams and dog owners.\"In addition to pursuing an indication for CID in dogs, Jaguar is also seeking conditional approval to market Canalevia for exercise-induced diarrhea (EID) in dogs. \"We expect that Canalevia could be available under conditional approval to treat both CID and EID in the first half of 2021,\" said Dr. Michael Guy, DVM, Ph.D., Jaguar's vice president of preclinical and nonclinical studies.Jaguar's wholly owned subsidiary, Napo Pharmaceuticals, Inc., currently markets a form of crofelemer, Mytesi®, which is the only non-opioid oral plant-based medicine approved by the FDA for the treatment of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy. Crofelemer, derived from the Croton lechleri tr...