Jaguar Health (NASDAQ:JAGX) has secured FDA renewal for Canalevia-CA1, a prescription drug used to treat chemotherapy-induced diarrhea (CID) in dogs. The renewal extends conditional approval until December 21, 2025, allowing the company to continue providing the only FDA-approved treatment for this condition while pursuing full approval.
Canalevia-CA1 is a canine-specific formulation of crofelemer, derived from the Croton lechleri tree. It is administered orally and is available through major U.S. veterinary distributors, including Chewy.
Ongoing Path to Full FDA Approval
Jaguar Health is actively working towards full FDA approval for Canalevia-CA1. The company has reached an agreement with the FDA on the design of a clinical field study to demonstrate substantial evidence of effectiveness. According to Dr. Michael Guy, D.V.M., M.S., Ph.D., Jaguar's Vice President of Preclinical and Nonclinical Studies, the extension was granted because the company was able to demonstrate active progress toward proving 'substantial evidence of effectiveness' of Canalevia-CA1 for treatment of CID in dogs for full approval, as required.
The Impact of Chemotherapy-Induced Diarrhea in Dogs
Chemotherapy-induced diarrhea is a common and distressing side effect for dogs undergoing cancer treatment. According to the American Veterinary Medical Association, approximately 1 in 4 dogs will develop cancer during their lifetime, with almost 50% of dogs over age 10 affected. The National Cancer Institute estimates that roughly 6 million new cancer diagnoses are made in dogs each year in the U.S.
Lisa Conte, Jaguar's president and CEO, stated, "Diarrhea is a highly neglected and unmet medical need in dogs and people undergoing cancer treatment. Jaguar is deeply committed to supporting the quality of life of people and animals undergoing cancer treatment."
Studies have indicated that CID is one of the three most prevalent side effects in dogs undergoing cancer treatment, and managing such side effects is crucial for maintaining successful cancer treatment. A Jaguar-sponsored survey revealed that more than half of U.S. veterinarians believe CID interferes with their patients' chemotherapy treatment plans, highlighting the need for effective treatments.
About Canalevia-CA1
Canalevia-CA1 (crofelemer delayed-release tablets) is an oral plant-based prescription product conditionally approved by the FDA for treating CID in dogs. It contains crofelemer, an active pharmaceutical ingredient isolated and purified from the Croton lechleri tree. The drug is administered orally twice a day and can be used for home treatment.
Safety Information
Canalevia-CA1 is for oral use in dogs only and should be kept out of reach of children and other animals. It is contraindicated in dogs with known hypersensitivity to crofelemer. Prior to use, infectious causes of diarrhea should be ruled out. Common adverse reactions include decreased appetite, decreased activity, dehydration, abdominal pain, and vomiting.
