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Jaguar Health Completes Filing of New Animal Drug Application for Conditional Approval of Canalevia-CA1 (Crofelemer) to Treat Chemotherapy-Induced Diarrhea in Dogs, Clearing Way for December 2021 Launch
Canalevia™-CA1 is the first and only oral plant-based prescription drug candidate for CID in dogsJaguar kicks off educational awareness contest in honor of
About this update from Jaguar Health, Inc.
[{"type":"text","content":"Canalevia™-CA1 is the first and only oral plant-based prescription drug candidate for CID in dogsJaguar kicks off educational awareness contest in honor of International Jaguar Day; Click here to enterSAN FRANCISCO, CA / ACCESSWIRE / November 2, 2021 / Jaguar Health, Inc. (NASDAQ:JAGX) today announced that it has completed the filing of the New Animal Drug Application (NADA) to request the U.S. Food and Drug Administration's conditional approval to market Canalevia™-CA1 (crofelemer delayed-release tablets), Jaguar's oral plant-based prescription drug candidate for the treatment of chemotherapy-induced diarrhea (CID) in dogs.\"All required major and minor technical sections of our application for conditional approval of Canalevia for CID in dogs have been deemed ‘Complete' by the CVM, and filing of the NADA is an administrative activity that results in approval for commercialization 60 days later. We are therefore now planning for the commercialization of Canalevia-CA1 for CID in dogs in late-December 2021,\" said Michael Guy, DVM, MS, Ph.D., Jaguar's vice president of preclinical and nonclinical studies.According to the National Cancer Institute, which is part of the National Institutes of Health, roughly 6 million new cancer diagnoses are made in dogs each year in the U.S. For the most part, dogs receive human chemotherapeutic agents during treatment and suffer the same side effects as humans, which means approximately 40% of treated dogs may have their chemotherapy reduced, changed, or discontinued due to diarrhea - which can compromise the full benefit of the chemotherapy agent.Chemotherapy is evolving to become the most widely-used oncology treatment modality in veterinary medicine. Moreover, the most prevalent and used targeted chemotherapy, tyrosine kinase inhibitors (TKIs), with substantial rates of diarrhea, are widely becoming adopted by small animal practitioners.There currently are no FDA-approved medications for the symptomatic treatment of CID in dogs.\"Treating CID is important to influence the outcome of a dog's cancer treatment, by allowing them to maintain a therapeutic dose, and to help with patient comfort and the dog's ability to maintain control, which is important for the home - the rug, couches, and general living environment,\" said Lisa Conte, Jaguar's president and chief executive officer and parent of ...