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 dogs
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"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
According to the
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
In addition to CID in dogs, Jaguar also plans to seek conditional approval from the CVM to market Canalevia for the treatment of exercise-induced diarrhea (EID) in dogs in 2022.
Canalevia-CA1 will be marketed as a prescription drug product of the company's
Jaguar Kicks Off Educational Awareness Contest in Honor of International Jaguar Day
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Certain statements in this press release constitute "forward-looking statements." These include statements regarding the expectation that Canalevia will be available under conditional approval for CID in