Business
Jaguar Health Clears Key Regulatory Hurdle on Path to 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 annually while undergoing chemotherapy SAN
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 annually while undergoing chemotherapy SAN FRANCISCO, CA / ACCESSWIRE / April 1, 2020 / Jaguar Health, Inc. (NASDAQ:JAGX) (\"Jaguar\" or the \"Company\") announced today that it has cleared a key regulatory hurdle in the Company's effort to gain U.S. Food and Drug Administration approval to market Canalevia™ (crofelemer delayed-release tablets) for the treatment of chemotherapy-induced diarrhea (\"CID\") in dogs.Jaguar has been informed by the FDA's Center for Veterinary Medicine (\"CVM\") that the CMC technical section, which covers the methods and controls Jaguar has in place for manufacturing, processing, and packaging of Canalevia, has been deemed Complete as part of the Company'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. The MU/MS designation is modeled on the orphan-drug designation for human drug development.According to the Company's current estimates, more than 230,000 dogs receive chemotherapy treatment for various cancers each year in the U.S., 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.Crofelemer, Canalevia's active ingredient, comes from the Croton lechleri tree, which is responsibly and sustainably harvested in South America. Canalevia, which is the first and only oral plant-based product candidate for CID in dogs, acts locally in the gut and does not interact with chemotherapy drugs.\"With FDA's confirmation that the CMC section of our application is complete, Jaguar is one step closer to receiving our first approved medicine indicated for animal use,\" said Jaguar president and chief executive officer Lisa Conte. \"We understand the deep bond between people and their dogs, and we are excited to move one step closer to bringing this important treatment option to dogs to alleviate CID, which may also help them better tolerate their chemotherapy.\"Jaguar's wholly owned subsidiary, Napo Pharmaceuticals, Inc. (\"Napo\"), currently markets Mytesi®, another form of crofelemer, for the treatment of noninfectious diarrhea in adult pa...